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Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer


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.

Inclusion Criteria


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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Survival rate at 18 months

Safety Issue:

No

Principal Investigator

Didier Blaise, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

Unspecified

Study ID:

CDR0000271936

NCT ID:

NCT00056095

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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