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CAMP 005 : MDR Gene Transfer Protocol For Advanced Cancer

A Pilot Study Of Gene Therapy For Advanced Cancer

CPMC IRB # 6383

Contents:

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OBJECTIVES

The two primary goals of this pilot study are to evaluate:

  1. Human multiple drug resistance (MDR) gene transfer and expression in CD34+ bone marrow cells of patients with advanced breast cancer, ovarian cancer and brain tumors who undergo high dose chemotherapy and autologous bone marrow transplantation (ABMT), and

  2. Any toxicity associated with MDR gene transfer.

CRITERIA FOR PATIENT ELIGIBILITY

Patients must fulfill all of the following criteria:

  1. Histologically confirmed diagnosis of breast cancer, epithelial ovarian cancer or glioblastoma, oligodendroglioma or medulloblastoma.

    Stage 4 breast cancer with a partial response to a conventional dose chemotherapy regimen.

    Stage 3 or 4 ovarian cancer, recurrent or residual disease after debulking surgery and at least 3 cycles of standard platinum based chemotherapy.

    Brain tumors: Newly diagnosed glioblastomas; or recurrent glioblastomas, anaplastic oligodendrogliomas, primary CNS lymphomas, primitive neuroectodermal tumors (PNETs), or ependymomas.

  2. No significant comorbid disease:

    Patients with a prior malignancy (other than carcinoma in situ of cervix or basal cell carcinoma of the skin) are eligible if they were treated curatively and have no evidence of active disease with five years of follow-up.

  3. Signed informed consent.

  4. Required Parameters:

Age 20 to 60
Performance status 0-1 (ECOG criteria)
White cell count >= 3000/ml
Platelet count >= 100,000/ml
Creat Clearance >= 60 ml/m
Bilirubin, SGOT <= 1.5 x normal
Ejection fraction >= 50%
DLCO > 60% predicted
Life expectancy > 2 months
HIV, Hb(s) Negative
Head CT: no CNS metastases (primary brain tumors remain eligible)
Bilateral marrow aspirates and biopsies: >30% cellularity, no tumor seen.
No bone metastases on bone scan (breast cancer only).
No active infection.
No prior pelvic radiation.
No pregnant or lactating women.

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Dennis Lu
Latest Revision: July 19, 1995