Clinical trial · Interventional
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
NCT00004135CI-TRIAL-00013974completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Fludarabine 30 mg/m2/d x S days IVPB in 100 cc NS over 30 minutes on day -8, -7, -6, -S, and -4. Cyclophosphamide 2 gm/m2/d x 2 days IVPB in SOO cc DS W over I hour on day -3 and day-2. G-CSF (Neupogen®) administration 480 f!gld subcutaneously starting on day +5 (or first day of neutropenia if earlier)and continued until an ANC of 0.5 x 109/L is maintained for 3 consecutive days.
- interventionNames
- Biological: filgrastim
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery * Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI * Measurable disease by radiography must be reproducible * Bony disease or effusions not measurable * No active CNS disease currently receiving radiotherapy or steroids * No effusion or ascites of more than 1 liter prior to drainage * HLA 5/6 or 6/6 matched sibling donor available * No known hypersensitivity to E. coli derived products * No active infection * No health condition that would preclude donation PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 g/dL * No active hepatitis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance greater than 50 mL/min Cardiovascular: * LVEF at least 50% Pulmonary: * DLCO at least 50% of predicted Other: * No active infection * HIV negative * No psychological problem that would preclude study compliance * No known hypersensitivity to E. coli derived products * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior systemic chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.