Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
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| ClinicalTrials.gov Identifier: NCT00056095 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : February 24, 2021
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Cancer | Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation | Phase 2 |
OBJECTIVES:
- Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
- Determine the objective rate of response of patients treated with this regimen.
- Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
- Determine the antitumoral activity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation.
- Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21.
- Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for group II) will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer |
| Actual Study Start Date : | November 4, 2002 |
| Actual Primary Completion Date : | February 13, 2008 |
| Actual Study Completion Date : | August 17, 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Allograft (compatible family member) |
Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
| Allograft (compatible non-family member) |
Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
- Survival rate at 18 months
- Objective rate of response
- Post-transplant immunological reactions and recuperation
- Antitumoral activity
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma
- No sarcomatoid, pure papillary, or Bellini renal cell cancer
- Measurable and/or evaluable disease
- Disease progression after at least 1 immunotherapy regimen for metastatic disease
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Localized metastases allowed provided the following are true:
- At least 3 months since prior treatment for metastases
- Not considered likely to influence outcome of transplantation
- No brain metastases unless treated surgically or radiologically and MRI normal
- Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- ECOG 0-1
Life expectancy
- More than 6 months
Hematopoietic
- Platelet count at least 100,000/mm^3
Hepatic
- Transaminases less than 1.5 times upper limit of normal (ULN)*
- Bilirubin less than 1.5 times ULN* NOTE: *Unless due to Gilbert's disease
Renal
- No renal insufficiency
- Calcium less than 10.4 mg/dL
- Creatinine clearance greater than 50 mL/min
Cardiovascular
- Ejection fraction greater than 50%
Pulmonary
- No DLCO that would preclude fludarabine or busulfan therapy
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No physical obstacle to receiving study treatment
- No known autoimmune disease
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled bacterial, viral, or fungal infection
- No prior or concurrent psychiatric disease
- HIV negative
- HTLV1 negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- No tolerance to fludarabine and busulfan
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056095
Show 26 study locations
| Study Chair: | Didier Blaise, MD | Institut Paoli-Calmettes |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00056095 |
| Other Study ID Numbers: |
UC-0160/0105 FRE-FNCLCC-GETUG-11/0105 ( Other Identifier: FNCLCC ) EU-20234 ( Other Identifier: European union ) |
| First Posted: | March 7, 2003 Key Record Dates |
| Last Update Posted: | February 24, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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recurrent renal cell cancer stage IV renal cell cancer |
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Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Cyclosporine Cyclophosphamide Fludarabine |
Fludarabine phosphate Cyclosporins Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Enzyme Inhibitors Antifungal Agents |