Clinical trial NCT00301093: Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Official title: Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Keywords: chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Beth Israel Deaconess Medical Center
First posted: 2006-03-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.

Detailed description: OBJECTIVES:

Primary

* Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
* Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.

Secondary

* Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
* Determine the development of tumor immunity in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of GM-K562.

Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 20 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of chronic myelogenous leukemia

  * Chronic phase disease
  * Philadelphia chromosome positive disease
* Disease in first complete hematologic response, defined by all of the following:

  * Complete normalization of peripheral blood counts with WBC \< 10,000/mm\^3
  * Platelet count \< 450,000/mm\^3
  * No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
* Persistent molecular evidence of disease

  * Detectable BCR-ABL transcript by quantitative polymerase chain reaction
  * Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
* Must have received imatinib mesylate for \> 1 year of which the last 3 months were at stable dose ≥ 300 mg/day

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* No known HIV
* ALT or AST ≤ 3 times upper limit of normal
* Oxygen saturation ≥ 93% at room air
* No history of recent acute myocardial infarction
* No history of unstable angina
* No pulmonary decomposition requiring hospitalization within the past 3 months
* No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior allogeneic stem cell transplantation
* At least 2 months since other prior experimental therapy
* At least 6 months since prior participation in another vaccine study
* No concurrent systemic immunosuppressive medication

Primary outcomes:
measure: Safety and Toxicity
timeFrame: 3 years
Secondary outcomes:
measure: Disease Response
timeFrame: 3 years
measure: Tumor immunity
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Martha Wadleigh, MD
role: PRINCIPAL_INVESTIGATOR
References: