Tipifarnib in Treating Patients With Advanced Hematologic Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00005967

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes	Drug: tipifarnib	Phase 1

Detailed Description

OBJECTIVES:

Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies.
Determine the safety profile of this drug in this patient population. III. Determine the clinical activity of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels.

Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.	Drug: tipifarnib

Arm

Intervention/Treatment

Experimental: Arm I

Drug: tipifarnib

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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