Tipifarnib in Treating Young Patients With Refractory Leukemia

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.

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

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborators: Children's Oncology Group; National Cancer Institute (NCI)
• Treatments: Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute lymphoblastic leukemia, acute nonlymphoblastic leukemia, juvenile myelomonocytic leukemia (JMML), or chronic myelogenous leukemia (CML) in blast crisis

• Refractory to standard curative therapy

• Acute promyelocytic leukemia refractory to tretinoin and arsenic trioxide

• Philadelphia chromosome-positive CML refractory to imatinib mesylate

• Greater than 25% blasts in bone marrow (M3 bone marrow) except for patients with JMML

• Active extramedullary disease allowed

• No active leptomeningeal leukemia

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• Karnofsky 50-100% (over 10 years of age)

• Lansky 50-100% (10 years of age and under)

Life expectancy:

• Not specified

Hematopoietic:

• Not required to be normal

Hepatic:

• Bilirubin normal

• SGPT and SGOT normal

• No significant hepatic dysfunction

• No grade 3 or 4 liver function test results within the past month

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

• No significant renal dysfunction

Cardiovascular:

• No significant cardiac dysfunction

Pulmonary:

• No significant pulmonary dysfunction

Neurologic:

• No history of grand mal seizures grade 3 or greater except febrile seizures

• No persistent sensory or motor neuropathy greater than grade 2

Other:

• No clinically significant unrelated systemic illness

• No serious infection

• No organ dysfunction that would preclude study participation

• No requirement for total parenteral nutrition

• No known allergy to azoles (e.g., clotrimazole, fluconazole, ketoconazole, voriconazole)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior colony-stimulating factor therapy (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) except epoetin alfa

• At least 3 months since prior myeloablative therapy followed by bone marrow or stem cell transplantation

• No concurrent immunotherapy

• No concurrent GM-CSF or interleukin-11

Chemotherapy:

• At least 2 weeks since prior chemotherapy

• No concurrent intrathecal chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• At least 1 week since prior corticosteroids

• No concurrent corticosteroids (except for acute allergic reaction)

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• Recovered from nonhematologic toxicity of all prior therapy

• At least 1 week since prior retinoids

• No antacids (magnesium- or aluminum-containing formulations) within 2 hours of study drug

• No other concurrent investigational agents

• No concurrent retinoids

• No concurrent anticonvulsants