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NCT00961220

O6-Benzylguanine and Topical Carmustine in Treating Patients With Early-Stage IA-IIA Cutaneous T-Cell Lymphoma

Completed Phase 1, PHASE2 Results posted Last updated 22 May 2018
What this trial tests

Phase 1, PHASE2 trial testing Carmustine in Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma in 17 participants. Completed in 8 April 2014.

Timeline
1 February 2010
Primary endpoint
8 April 2012
8 April 2014

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date1 February 2010
Primary completion8 April 2012
Estimated completion8 April 2014
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

19 and older, any sex, with Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma or Stage I Mycosis Fungoides and Sezary Syndrome AJCC v7. 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.

Overall Response Rate Primary · Up to 2 weeks after completion of study treatment

Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness. CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score c

Complete Clinical Response-confirmed
GroupValue95% CI
Treatment (O6-benzylguanine, Carmustine)6
Complete Clinical Response-unconfirmed
GroupValue95% CI
Treatment (O6-benzylguanine, Carmustine)2
Partial Response
GroupValue95% CI
Treatment (O6-benzylguanine, Carmustine)8
Progressive Disease
GroupValue95% CI
Treatment (O6-benzylguanine, Carmustine)1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from during treatment over a 6 month time period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (O6-benzylguanine, Carmustine)
Serious: 0/17 (0%)
Deaths:
Other adverse events (27 terms — click to expand)

ReactionSystemTreatment (O6-benzylguanin…
CUTANEOUS HYPERPIGMENTATIONSkin and subcutaneous tissue disorders
RASH/ DESQUAMATIONSkin and subcutaneous tissue disorders
FATIGUEGeneral disorders
PAIN OF SKINSkin and subcutaneous tissue disorders
PRURITUSSkin and subcutaneous tissue disorders
TRANSAMINASE ELEVATIONInvestigations
HEADACHENervous system disorders
NAUSEAGastrointestinal disorders
ANEMIABlood and lymphatic system disorders
DIZZINESSNervous system disorders
DRY SKINSkin and subcutaneous tissue disorders
INJECTION SITE REACTION or PAINGeneral disorders
URIC ACID ELEVATIONRenal and urinary disorders
URINE SPECIFIC GRAVITY ELEVATEDRenal and urinary disorders
ACNEIFORM RASHSkin and subcutaneous tissue disorders
ALKALINE PHOSPHATASE ELEVATEDInvestigations
BLOATINGGastrointestinal disorders
CONSTIPATIONGastrointestinal disorders
CREATININE ELEVATIONInvestigations
GLUCOSE LOWMetabolism and nutrition disorders
JOINT PAINSMusculoskeletal and connective tissue disorders
LEUKOPENIABlood and lymphatic system disorders
MONOCYTE ELEVATIONBlood and lymphatic system disorders
MYALGIAMusculoskeletal and connective tissue disorders
SKIN ULCERATIONSkin and subcutaneous tissue disorders
TELANGIECTASIASkin and subcutaneous tissue disorders
TOTAL BILIRUBIN ELEVATEDInvestigations

Data from ClinicalTrials.gov NCT00961220 adverse events section.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of carmustine when given together with O6-benzylguanine and to see how well they work in treating patients with stage IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill more cancer cells.

Publications & conference data

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

  1. Phase I clinical trial of O6-benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, mycosis fungoides type.
    Apisarnthanarax N, Wood GS, Stevens SR, Carlson S, et al · · 2012 · cited 15× · PMID 22250189 · DOI 10.1001/archdermatol.2011.2797
  2. Evaluation of O6-Benzylguanine-Potentiated Topical Carmustine for Mycosis Fungoides: A Phase 1-2 Clinical Trial.
    Tacastacas JD, Chan DV, Carlson S, Gerson SL, et al · · 2017 · cited 6× · PMID 28199478 · DOI 10.1001/jamadermatol.2016.5793

Verify or expand the search:

Other trials of Carmustine

Trials testing the same drug.

Other recruiting trials for Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00961220.

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