NCT00301067 is a Phase 1, PHASE2 clinical trial of Calcitriol in Metastatic Melanoma, sponsored by Northwestern University.

Who is sponsoring NCT00301067?

NCT00301067 is sponsored by Northwestern University.

What drugs are being tested in NCT00301067?

Interventions in NCT00301067: Calcitriol, Temozolomide.

What condition does NCT00301067 study?

NCT00301067 studies Metastatic Melanoma.

Is NCT00301067 still recruiting?

NCT00301067 is currently completed. Last updated 4 June 2019.

Are results published for NCT00301067?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-04 · How we verify

NCT00301067

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

Completed Phase 1, PHASE2 Results posted Last updated 4 June 2019

What this trial tests

Phase 1, PHASE2 trial testing Calcitriol in Metastatic Melanoma in 20 participants. Completed in 9 July 2012.

Timeline

30 January 2005

Primary endpoint
5 April 2012

9 July 2012

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	30 January 2005
Primary completion	5 April 2012
Estimated completion	9 July 2012
Sites	1 location across United States

Drugs / interventions tested

Calcitriol (CALCITRIOL) — full drug profile →
Temozolomide (temozolomide) — full drug profile →

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number and Frequency of Dose Limiting Toxicities (DLTs) With High-dose Calcitriol in Combination With Temozolomide Primary · From start of treatment, up to 12 cycles where 1 cycle equals 28 days

Determine number and frequency of dose limiting toxicities (DLT) of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 cycles of therapy, where 1 cycle equals 28 days. 3 patients per dose cohort will be entered into the trial at doses of 0.2, 0.3, and 0.5 mcg/kg of calcitriol administered orally. If 1 patient experiences dose limiting toxicity (DLT) at any dose, that dose cohort will be expanded to a maximum of 6 patients. If 1 additional patient experiences DLT at that dose stratum, further dose escalation will cease and the dose cohort

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0

Number of Patients With Toxicity Primary · From the start of treatment and every 2 weeks for a maximum of 12 cycles, and 30 days post last treatment, where 1 cycle equals 28 days

Toxicity will be assessed for each patient on a seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 cycles where 1 cycle equals 28 days. Toxicity will be assessed during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) and defined by any toxicity determined to be at least possibly related to either study drug (temozolomide or calcitriol). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Sev

Thrombocytopenia

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	1
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0
Expansion - Temozolomide and Calcitriol	1

Vascular

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	1
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0
Expansion - Temozolomide and Calcitriol	1

Nausea

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	1
Expansion - Temozolomide and Calcitriol	0

Vomiting

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	1
Expansion - Temozolomide and Calcitriol	0

Leukopenia

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	1
Expansion - Temozolomide and Calcitriol	1

Fatigue

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0
Expansion - Temozolomide and Calcitriol	1

Anemia

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0
Expansion - Temozolomide and Calcitriol	2

Lymphopenia

Group	Value	95% CI
Cohort 1 - Temozolomide and Calcitriol	0
Cohort 2 - Temozolomide and Calcitriol	0
Cohort 3 - Temozolomide and Calcitriol	0
Expansion - Temozolomide and Calcitriol	2

Tumor Response Secondary · At baseline and every 8 weeks during treatment for a maximum of 12 cycles where one cycle equals 28 days.

Determine best tumor response during treatment. Response and progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesi

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	0
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	2
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	1
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	17

Overall Response Rate Secondary · From the start of treatment, every 2 cycles where 1 cycle equals 28 days, for a maximum of 12 cycles

Overall Response Rate (ORR) is defined as percentage of patients who's best response to treatment is complete response plus those with partial response. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	2

Time to Progression Secondary · From the start of treatment, until progressive disease, up to 12 months

Time to progression (TTP) is measured from the start of treatment until the time of first documentation of disease progression.

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	1.81	1.15 – 1.99

Overall Survival Secondary · From the first day of treatment until death from any cause, up to a maximum of 6 and half years

Overall Survival (OS) will be measured from first day of treatment until death of any cause. Patients still alive at the last data cut off point will be censored.

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	5.5	2.7 – 12.3

Overall Survival (OS) Stratified by Vitamin D-Receptor (VDR) Gene Polymorphisms Secondary · at baseline and until death from any cause up to 6 and half years

Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and Overall Survival (OS). VDR gene analysis was completed using PCR-RFLP based assays.

VDR genotype (tt+/-ff)

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	3.8	2.0 – 5.7

non tt+/-ff VDR genotype

Group	Value	95% CI
Temozolomide and Calcitriol (Cohort 1-3+Expansion)	7.4	3.0 – 12.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events for the study were collected over a 6 year and 3 month period. For each patient adverse events were collected for a maximum of 12 cycles where 1 cycle equals 28 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 - Temozolomide and Calcitriol

Serious: 2/4 (50%)

Deaths: 3/4

Cohort 2 - Temozolomide and Calcitriol

Serious: 1/3 (33%)

Deaths: 3/3

Cohort 3 - Temozolomide and Calcitriol

Serious: 2/3 (67%)

Deaths: 3/3

Expansion - Temozolomide and Calcitriol

Serious: 4/10 (40%)

Deaths: 9/10

Serious adverse events (10 terms)

Reaction	System	Cohort 1 - Temozolomide an…	Cohort 2 - Temozolomide an…	Cohort 3 - Temozolomide an…	Expansion - Temozolomide a…
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Nausea and vomiting	Gastrointestinal disorders	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—
Rapidly declining performance status	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Confusion	Nervous system disorders	—	—	—	—
Slurred speech and drooling	Nervous system disorders	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary embolus	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Death related to disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—

Other adverse events (58 terms — click to expand)

Reaction	System	Cohort 1 - Temozolomide an…	Cohort 2 - Temozolomide an…	Cohort 3 - Temozolomide an…	Expansion - Temozolomide a…
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Anemia (Hemoglobin decrease)	Blood and lymphatic system disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Weight loss	General disorders	—	—	—	—
Anorexia	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Leukocytes (white blood count)	Blood and lymphatic system disorders	—	—	—	—
Transaminase	Metabolism and nutrition disorders	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—
Platelets decreased (thrombocytopenia)	Blood and lymphatic system disorders	—	—	—	—
Urinary tract infection NOS	Infections and infestations	—	—	—	—
Oral infection	Infections and infestations	—	—	—	—
Albumin, serum-low	Metabolism and nutrition disorders	—	—	—	—
Bilirubin, serum high	Metabolism and nutrition disorders	—	—	—	—
Glucose, serum high	Metabolism and nutrition disorders	—	—	—	—
Lactic acid dehydrogenase (LDH) increase	Metabolism and nutrition disorders	—	—	—	—
Confusion	Nervous system disorders	—	—	—	—
Mood alteration - Depression	Psychiatric disorders	—	—	—	—
Motor Neuropathy	Nervous system disorders	—	—	—	—
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Pain not otherwise specified	General disorders	—	—	—	—
Neutrophils decreased	Blood and lymphatic system disorders	—	—	—	—
Hypotension	Cardiac disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Sweating	General disorders	—	—	—	—
Weight gain	General disorders	—	—	—	—
Hyperpigmentation	Skin and subcutaneous tissue disorders	—	—	—	—
Rash/desquamation	Skin and subcutaneous tissue disorders	—	—	—	—
Dehydration	Gastrointestinal disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Blood in stool	Gastrointestinal disorders	—	—	—	—
Hemorrhage CNS	Gastrointestinal disorders	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Limb edema	Blood and lymphatic system disorders	—	—	—	—
Edema in head and neck	Blood and lymphatic system disorders	—	—	—	—
Alkaline phosphatase	Metabolism and nutrition disorders	—	—	—	—
Bicarbonate - low	Metabolism and nutrition disorders	—	—	—	—

Most-reported serious reactions: Thrombocytopenia, Nausea and vomiting, Hyperglycemia, Rapidly declining performance status, Confusion, Slurred speech and drooling, Pneumonia, Pulmonary embolus.

Data from ClinicalTrials.gov NCT00301067 adverse events section.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Natural compounds as anticancer agents: Experimental evidence.
Wang J, Jiang YF. · · 2012 · cited 56× · PMID 24520533 · DOI 10.5493/wjem.v2.i3.45
Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials.
Jeter JM, Bowles TL, Curiel-Lewandrowski C, Swetter SM, et al · · 2019 · cited 23× · PMID 30281145 · DOI 10.1002/cncr.31719
Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
Dickkopf Proteins and Their Role in Cancer: A Family of Wnt Antagonists with a Dual Role.
Giralt I, Gallo-Oller G, Navarro N, Zarzosa P, et al · · 2021 · cited 15× · PMID 34451907 · DOI 10.3390/ph14080810
Double-sided niche regulation in skin stem cell and cancer: mechanisms and clinical applications.
Pham TTQ, Kuo YC, Chang WL, Weng HJ, et al · · 2025 · cited 2× · PMID 40399946 · DOI 10.1186/s12943-025-02289-8

Verify or expand the search:

Other trials of Calcitriol

Trials testing the same drug.

NCT06261905 — Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System · Phase 1 · completed
NCT05415254 — Calcitriol Supplementation in COVID-19 Patients · NA · unknown
NCT04801303 — Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients · Phase 4 · completed
NCT05765617 — Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients · Phase 2 · completed
NCT04967469 — Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in · NA · completed

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting

Other Northwestern University trials

Trials by the same sponsor.

NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies · Phase 1, PHASE2 · not yet recruiting
NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00301067 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 4 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00301067.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing