Tipifarnib in Treating Patients With Advanced Hematologic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists

• Hodgkin's or non-Hodgkin's lymphoma

• Known bone marrow involvement

• Acute myeloid leukemia

• Chronic myelogenous leukemia

• Chronic phase

• No significant symptoms after treatment

• No features of accelerated phase or blastic phase

• Accelerated phase

• WBC difficult to control with conventional busulfan or hydroxyurea in terms of dose requirement or shortening of intervals between courses

• Rapid doubling of WBC (less than 5 days)

• At least 10% blasts in blood or marrow

• At least 20% blasts plus promyelocytes in blood or marrow

• At least 20% basophils plus eosinophils in blood

• Anemia or thrombocytopenia unresponsive to busulfan or hydroxyurea

• Persistent thrombocytosis

• Additional chromosome changes

• Increasing splenomegaly

• Development of chloromas or myelofibrosis

• Blastic phase

• At least 30% blasts plus promyelocytes in blood or bone marrow

• Acute lymphoblastic leukemia

• Chronic lymphocytic leukemia

• Myelodysplastic syndromes

• Refractory anemia with excess blasts (RAEB)

• Chronic myelomonocytic leukemia

• RAEB in transformation

• Multiple myeloma

• Chronic myeloproliferative diseases including, but not limited to, myelofibrosis with myeloid metaplasia

• Measurable or evaluable disease documented by radiographic, hematologic, bone marrow, or clinical examination parameters

• Refusal of allogeneic bone marrow transplantation allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Albumin at least 2.5 g/dL

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• No other uncontrolled medical disorder

• No active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

Chemotherapy:

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

• At least 3 days since prior hydroxyurea

Endocrine therapy:

• At least 4 weeks since prior systemic steroids for multiple myeloma

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• No prior total gastrectomy or total ileocolectomy

Other:

• No prior tipifarnib

• No concurrent proton pump inhibitors (e.g., omeprazole)