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STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
daunorubicin hydrochloride
imatinib mesylate
prednisone
vincristine sulfate
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: One of the following diagnoses: Chronic myelogenous leukemia in lymphoid blast crisis Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction No more than 1 prior course of induction chemotherapy Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization At least 30% blasts in bone marrow Ineligible for or refused allogeneic stem cell transplantation Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) ALT and AST less than 3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior allogeneic bone marrow or peripheral blood stem cell transplantation At least 48 hours since prior interferon alfa Chemotherapy: See Disease Characteristics At least 24 hours since prior hydroxyurea At least 6 weeks since prior busulfan Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior therapy for blast crisis except hydroxyurea No prior salvage or reinduction therapy for Ph+ ALL At least 4 weeks since other prior investigational agents

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • Stanford University Medical Center
  • Oregon Cancer Institute
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
June 20, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00015860
Brief Title
STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
Official Title
A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of daunorubicin when combined with imatinib mesylate, vincristine, and prednisone in patients with lymphoid blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. Determine the safety of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. Determine the frequency of hematologic and cytogenetic responses in patients treated with this regimen. Determine the duration of response of this patient population treated with this regimen. Determine the survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of daunorubicin. Patients who have not previously received imatinib mesylate receive oral imatinib mesylate on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive daunorubicin IV over 2-3 minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral prednisone on days 1-28. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of daunorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose. PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following diagnoses: Chronic myelogenous leukemia in lymphoid blast crisis Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction No more than 1 prior course of induction chemotherapy Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization At least 30% blasts in bone marrow Ineligible for or refused allogeneic stem cell transplantation Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) ALT and AST less than 3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior allogeneic bone marrow or peripheral blood stem cell transplantation At least 48 hours since prior interferon alfa Chemotherapy: See Disease Characteristics At least 24 hours since prior hydroxyurea At least 6 weeks since prior busulfan Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior therapy for blast crisis except hydroxyurea No prior salvage or reinduction therapy for Ph+ ALL At least 4 weeks since other prior investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Paquette, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
Oregon Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia

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