Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Case Comprehensive Cancer Center
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
* Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
* Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Diagnosis of metastatic colorectal carcinoma
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
At least 12 weeks
Hematopoietic:
WBC at least 4,000/mm\^3
Granulocyte count at least 1,500/mm\^3
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
Hemoglobin greater than 8 g/dL
Hepatic:
Bilirubin no greater than 1.2 mg/dL
AST and ALT less than 2.5 times upper limit of normal (ULN)
PT no greater than ULN (not on anticoagulation therapy)
Renal:
Creatinine no greater than 1.5 mg/dL
Creatine clearance greater than 60 mL/min
Pulmonary:
DLCO at least 60%
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study
No other concurrent active malignancies
Prior malignancies presumed to be cured allowed
No other concurrent uncontrolled severe medical problem that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 6 months since prior adjuvant chemotherapy without disease recurrence
No more than 1 prior chemotherapy regimen for metastatic disease
Endocrine therapy:
Not specified
Radiotherapy:
Prior adjuvant radiotherapy allowed
No prior radiotherapy to more than 25% of total bone marrow
