Overview

Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Irinotecan
Criteria
Inclusion Criteria:

- Histologically proven solid tumor or lymphoma

- Responded to irinotecan OR no existing curative therapy

- No leukemia

- Measurable or evaluable disease

- Performance status - Karnofsky 70-100%

- WBC at least 3500/mm^3

- Absolute neutrophil count at least 1500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

- SGOT/SGPT less than 5 times upper limit of normal (unless due to disease)

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No inflammatory bowel disease requiring therapy

- No chronic diarrhea syndrome or paralytic ileus

- At least 2 weeks since prior colony stimulating factor

- At least 4 weeks since prior biologic therapy

- No concurrent biologic therapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No other concurrent chemotherapy

- At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow

- No concurrent palliative radiotherapy

- No prior transplant

- No concurrent substrates of UGT1A1 enzyme

- No concurrent inducers or inhibitors of UGT1A1 enzyme activity