Last reviewed · How we verify
Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of 12/01/2009)
Phase 1 trial testing filgrastim in Fallopian Tube Cancer in 12 participants. Completed in 3 August 2021.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 16 October 2007 |
| Primary completion | 3 August 2021 |
| Estimated completion | 3 August 2021 |
| Sites | 1 location across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
Adults 18 to 120, female only, with Fallopian Tube Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participant toxicity will be evaluated by using NCI CTCAE v3.0
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 3 | |
| WT1 Specific T Cells 2 x 10^7/m2 | 3 | |
| WT1 Specific T Cells 5 x 10^7/m2 | 4 | |
| WT1 Specific T Cells 1 x 10^8/m2 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 0 | |
| WT1 Specific T Cells 2 x 10^7/m2 | 0 | |
| WT1 Specific T Cells 5 x 10^7/m2 | 0 | |
| WT1 Specific T Cells 1 x 10^8/m2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 11.7 | 1.5 – 21.9 |
| WT1 Specific T Cells 2 x 10^7/m2 | 5.7 | 1 – 12 |
| WT1 Specific T Cells 5 x 10^7/m2 | 22.5 | 1 – 32 |
| WT1 Specific T Cells 1 x 10^8/m2 | 21.4 | 20 – 22.8 |
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 0 | |
| WT1 Specific T Cells 2 x 10^7/m2 | 0 | |
| WT1 Specific T Cells 5 x 10^7/m2 | 1 | |
| WT1 Specific T Cells 1 x 10^8/m2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 3 | |
| WT1 Specific T Cells 2 x 10^7/m2 | 3 | |
| WT1 Specific T Cells 5 x 10^7/m2 | 3 | |
| WT1 Specific T Cells 1 x 10^8/m2 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 0 | |
| WT1 Specific T Cells 2 x 10^7/m2 | 0 | |
| WT1 Specific T Cells 5 x 10^7/m2 | 0 | |
| WT1 Specific T Cells 1 x 10^8/m2 | 0 |
Time frame: 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | WT1 Specific T Cells 5 x 1… | WT1 Specific T Cells 2 x 1… | WT1 Specific T Cells 5 x 1… | WT1 Specific T Cells 1 x 1… |
|---|---|---|---|---|---|
| Death not assoc with CTCAE term - Death NOS | General disorders | — | — | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Inf norm ANC/gr1/2 neut-Cellulitis(skin) | Infections and infestations | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Small bowel obstruction - NOS | Gastrointestinal disorders | — | — | — | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Inf norm ANC/gr1/2 neut-Pneumonia(lung) | Infections and infestations | — | — | — | — |
| Pulmonary/upper respiratory - Other | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Reaction | System | WT1 Specific T Cells 5 x 1… | WT1 Specific T Cells 2 x 1… | WT1 Specific T Cells 5 x 1… | WT1 Specific T Cells 1 x 1… |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Pain - Pelvis | Reproductive system and breast disorders | — | — | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — | — | — |
| Chronic kidney disease | Renal and urinary disorders | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — |
| Inf norm ANC/gr1/2 neut-Cellulitis(skin) | Infections and infestations | — | — | — | — |
| Pain - Abdomen NOS | Gastrointestinal disorders | — | — | — | — |
| Small Bowel Obstruction | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
Most-reported serious reactions: Death not assoc with CTCAE term - Death NOS, Pelvic pain, Fatigue, Inf norm ANC/gr1/2 neut-Cellulitis(skin), Hypomagnesemia, Small bowel obstruction - NOS, Chest wall pain, Inf norm ANC/gr1/2 neut-Pneumonia(lung).
Data from ClinicalTrials.gov NCT00562640 adverse events section.
RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected. Treating stem cells collected from the patient's blood in the laboratory may increase the number of immune cells that can mount an immune response against the tumor. The treated stem cells may help destroy any remaining tumor cells (graft-versus-tumor effect). Chemotherapy may also be given to the patient to prepare the bone marrow for the stem cell transplant. PURPOSE: This phase I trial is studying the side effects and best dose of autologous T cells when given with or without cyclophosphamide and fludarabine in treating patients with recurrent or persistent advanced ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. (fludarabine treatment closed as of 12/012009)
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT00562640.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing