R115777 in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2001-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have refractory or recurrent acute leukemia or chronic myelogenous leukemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT00101296

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Erythroid Leukemia (M6) Adult Acute Megakaryoblastic Leukemia (M7) +16 more

COMPLETED PHASE1

CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase

NCT00084916

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) +12 more

COMPLETED PHASE2

Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

NCT00027872

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia +18 more

COMPLETED PHASE2

Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

NCT00093470

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia Adult Acute Monocytic Leukemia +14 more

COMPLETED PHASE3

A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.

NCT00354146

Leukemia, Nonlymphocytic, Acute

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES: I. Determine toxicities and pharmacokinetics of oral R115777 in adults with refractory acute leukemia or accelerated or blastic phase chronic myelogenous leukemia. II. Determine the effect of R115777 on farnesylation within leukemia cells. III. Determine any clinical response (at least 50% decrease in circulating leukemia cells) to R115777 by these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive oral R115777 for 7-21 days. Patients who achieve complete response (CR) or partial response (PR) following 1-4 courses of treatment may receive up to 4 additional courses. Patients with stable disease may receive another 7-21 day course. If CR or PR is then achieved, patients may receive up to 4 additional courses. Cohorts of 6-12 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which between 17% and 33% of patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tipifarnib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No hyperleukocytosis (at least 50,000 leukemic blasts/mm3) Hepatic: Bilirubin normal SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 2 times normal Cardiovascular: LVEF at least 45% by MUGA or echocardiogram No myocardial infarction within the past 3 months No severe coronary artery disease No cardiomyopathy No congestive heart failure No prior coagulation related sequelae: Deep vein thrombosis Pulmonary embolus CNS thrombosis or bleed Other: No pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior growth factors (epoetin alfa, filgrastim, sargramostim, interleukin-3, interleukin-11) and recovered No prior allogeneic bone marrow transplantation No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior extensive radiotherapy to greater than 25% bone marrow No concurrent radiotherapy Surgery: Not specified

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No