Clinical trial · Interventional
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
- 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 followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy + stem cell transplantation
- description
- Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6. After day 120, patients with persistent disease and no signs of active GVHD may receive donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2 infusions. Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every 2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.
- interventionNames
- Biological: filgrastim
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Drug: methotrexate
- Drug: tacrolimus
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (5)
- measure
- Overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma (RCC)
* Clear cell or papillary RCC
* Granular tumors with sarcomatoid features
* No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma
* No transitional cell carcinoma of the renal pelvis and collecting systems
* Metastatic or unresectable disease
* At least 1 measurable lesion
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* The following are not considered measurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Primary bladder masses
* Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies
* No prior or concurrent CNS metastases
* Negative MRI of the brain within the past 28 days
* Must have HLA-identical (6/6) sibling donor
PATIENT CHARACTERISTICS:
Age:
* 60 and under
Performance status:
* ECOG 0-1
Life expectancy:
* More than 6 months
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
Renal:
* Creatinine clearance at least 40 mL/min
Cardiovascular:
* LVEF at least 45% by MUGA or echocardiogram
Pulmonary:
* DLCO greater than 40% of predicted (corrected for hemoglobin level)
* No symptomatic pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known hypersensitivity to E. coli-derived products
* No uncontrolled diabetes mellitus
* No active serious infection
* No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No concurrent sargramostim (GM-CSF)
* Concurrent epoetin alfa allowed
Chemotherapy:
* No other concurrent chemotherapy
Endocrine therapy:
* At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy)
* Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
* At least 14 days since prior radiotherapy
Surgery:
* At least 14 days since prior surgery
Other:
* At least 28 days since prior systemic therapy for RCC
* Recovered from prior therapyReferences
Publications (1)
- RESULTRini BI, Halabi S, Barrier R, Margolin KA, Avigan D, Logan T, Stadler WM, McCarthy PL, Linker CA, Small EJ; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; Southwestern Oncology Group. Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study. Biol Blood Marrow Transplant. 2006 Jul;12(7):778-85. doi: 10.1016/j.bbmt.2006.03.011. PMID 16785067