Clinical trial NCT00027573: Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
Official title: Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
papillary renal cell carcinoma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 36
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation.
* Determine the toxicity and treatment-related mortality of this regimen in these patients.
* Determine the percentage of donor chimerism in patients treated with this regimen.

Eligibility criteria: 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 therapy

Primary outcomes:
measure: Overall response rate
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
measure: Disease-free survival
timeFrame: Up to 5 years
measure: Treatment-related mortality
timeFrame: Up to 5 years
measure: Percentage of donor chimerism in patients treated
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Mayo Clinic Scottsdale Oncology Program
state: Arizona
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Hackensack
country: United States
facility: CCOP - Northern New Jersey
state: New Jersey
city: Tulsa
country: United States
facility: CCOP - Oklahoma
state: Oklahoma
Study officials:
affiliation: University of California, San Francisco
name: Brian I. Rini, MD
role: STUDY_CHAIR
References:
citation: Rini 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.