Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027573
• Other study ID #: CALGB-90003
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: July 12, 2016
• Start date: October 2001
• Est. completion date: June 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• filgrastim

• therapeutic allogeneic lymphocytes

Drug:
• cyclophosphamide

• fludarabine phosphate

• methotrexate

• tacrolimus

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	CCOP - Oklahoma	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 transp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Up to 5 years	No
Primary	Overall survival		Up to 5 years	No
Primary	Disease-free survival		Up to 5 years	No
Primary	Treatment-related mortality		Up to 5 years	Yes
Primary	Percentage of donor chimerism in patients treated		Up to 5 years	No