Know Cancer

or
forgot password

Phase I/II Study of the Farnesyltransferase Inhibitor R115777 (NSC 702818) in Patients With Myeloproliferative Disorders


Phase 1/Phase 2
21 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic/Myeloproliferative Neoplasms

Thank you

Trial Information

Phase I/II Study of the Farnesyltransferase Inhibitor R115777 (NSC 702818) in Patients With Myeloproliferative Disorders


OBJECTIVES:

- Determine the toxic effects of tipifarnib in adult patients with myeloproliferative
disorders.

- Determine hematological responses, including changes in WBC count and erythroid
responses, in this patient population treated with this drug.

- Determine the cytogenetic response in bone marrow of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior substantive
treatment (yes vs no).

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 4 weeks
for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression.
Patients with continued hematologic response after completion of the fourth course may
receive additional courses at the discretion of the investigator.

PROJECTED ACCRUAL: A total of 25 patients (12-13 per stratum) will be accrued for this study
within 25 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic myelogenous leukemia (CML)

- Philadelphia chromosome (Ph) positive OR

- BCR-ABL positive by polymerase chain reaction

- Must meet 1 of the following 2 conditions:

- Chronic phase

- Persistent or progressive disease on maximum tolerated interferon or
imatinib mesylate, as evidenced by increasing WBC count, peripheral
blood myeloid immaturity, progressive anemia, and/or persistence or
relapse of abnormal cytogenetics and/or molecular findings

- Interferon or imatinib mesylate intolerant

- Accelerated phase

- Persistent or progressive disease on imatinib mesylate

- Patients who have not received interferon or imatinib mesylate due to
allergy or refusal are eligible OR

- Diagnosis of chronic myelomonocytic leukemia

- Proliferative type (WBC at least 12,000/mm3)

- Less than 5% blasts in peripheral blood and no more than 20% blasts in bone
marrow OR

- Diagnosis of undifferentiated myeloproliferative disorder OR

- Diagnosis of atypical CML (Ph negative)

- No blast crisis phase of CML, atypical CML, or undifferentiated myeloproliferative
disorders

- No more than 20% blasts in peripheral blood or bone marrow

- Diagnosed more than 3 months before study entry

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 4 months

Hematopoietic:

- See Disease Characteristics

- No requirement for platelet transfusion

- No thrombocytopenia-related bleeding

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2 times ULN

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Capable of swallowing capsules

- No other concurrent severe disease that would preclude study compliance

- No septicemia or other severe infection

- No iron deficiency

- If marrow aspirate not available, transferrin saturation at least 20% and
ferritin greater than 50 ng/mL

- No other contributing causes of anemia (e.g., autoimmune or hereditary hemolytic
disorders, gastrointestinal blood loss, B12 or folate deficiency, or hypothyroidism)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- At least 4 weeks since prior interferon

- At least 4 weeks since prior hematopoietic growth factors

- No prior allogeneic bone marrow transplantation

Chemotherapy:

- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or
nitrosoureas) except for hydroxyurea which may be used to manage elevated cell counts
through the beginning of the second course of study therapy

Endocrine therapy:

- No concurrent androgens

- No concurrent corticosteroids (e.g., greater than 10 mg/day prednisone or equivalent
steroid dosage) except as premedication for transfusions

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent standard or investigational cytotoxic agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter L. Greenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000067864

NCT ID:

NCT00005846

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasms
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • Neoplasms
  • Leukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642