Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase

NCT00383474 | Completed Phase 1

• 6 other identifiers: NCI-2009-00147CDR0000502258MCC-147967306N01CM62208P30CA076292
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in treating patients with acute leukemia or chronic myelogenous leukemia in blast phase. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.

Conditions

Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Blastic Phase; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Disease; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity and maximum tolerated dose of tipifarnib and bortezomib

  21 days

Secondary Outcomes (4)

• Changes in apoptotic protein expression (Bim, Bax, AKT)

  Baseline and day 8

• Clinical efficacy (response rate) evaluated using the revised International Working Group Criteria (IWG) for AML

  Up to 3 years

• Farnesytransferase and proteasome inhibition in peripheral blood mononuclear cells

  Day 8

• Farnesytransferase and proteasome inhibition in peripheral blood mononuclear cells

  Day 15

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive an infusion of bortezomib twice a week for 2 weeks. They will also receive tipifarnib by mouth twice a day for 2 weeks.

Drug: Bortezomib; Other: Laboratory Biomarker Analysis; Drug: Tipifarnib

Interventions

Bortezomib DRUG

Given IV

Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade

Arm I

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I

Tipifarnib DRUG

Given orally

Also known as: R115777, Zarnestra

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets 1 of the following disease-specific criteria:
• Relapsed disease after =\< 2 prior chemotherapy regimens (consolidation therapy excluded)
• Primary-induction failure
• Previously untreated and deemed unfit for or refusing cytotoxic chemotherapy
• No hyperleukocytosis (leukemic blasts \>= 30,000/mm\^3)
• No acute promyelocytic leukemia (M3)
• No active CNS leukemia
• SGOT and SGPT =\< 2 times upper limit of normal (ULN)
• Bilirubin normal
• Creatinine =\< 1.5 times ULN
• No uncontrolled hypertension, congestive heart failure, angina pectoris, or ventricular dysrhythmias
• Not pregnant or nursing
• Negative pregnancy test
• No uncontrolled disseminated intravascular coagulation
• Fertile patients must use effective contraception

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Myeloid, Acute; Leukemia, Erythroblastic, Acute; Blast Crisis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Interventions

Bortezomib; tipifarnib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Lancet

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 15, 2015

Record last verified: 2013-04

Locations

US (1)