Clinical trial NCT00047021: Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
Official title: A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Keywords: accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
childhood chronic myelogenous leukemia
atypical chronic myeloid leukemia
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 3
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.

Detailed description: OBJECTIVES:

* Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.
* Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.

OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* One of the following must be present:

  * Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia

    * More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy
    * Failed at least 1 attempt at induction chemotherapy
  * Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma

    * Refractory or relapsed after at least 1 regimen of standard chemotherapy
  * Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis

    * Received at least 1 myelotoxic chemotherapy regimen
* Active CNS involvement allowed

PATIENT CHARACTERISTICS:

Age

* 55 and under

Performance status

* ECOG 0-2

Life expectancy

* At least 5 weeks

Hematopoietic

* Lymphoma patients:

  * WBC at least 2,000/mm\^3\*
  * Platelet count at least 20,000/mm\^3\* NOTE: \*Unless due to bone marrow involvement or disease process

Hepatic

* Bilirubin no greater than 3 times normal\*
* AST/ALT no greater than 3 times normal\*
* Alkaline phosphatase no greater than 3 times normal\*
* No severe liver failure NOTE: \*Unless related to leukemia

Renal

* Creatinine clearance greater than 50 mL/min
* No severe renal failure

Cardiovascular

* LVEF at least 45% by MUGA

Pulmonary

* DLCO at least 60% of predicted

Other

* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric illness that would preclude informed consent
* No medical illness or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics
* At least 24 hours since prior hydroxyurea
* At least 1 week since other prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Recovered from prior therapy

Primary outcomes:
measure: Event free survival at day 14 (myeloid engraftment)
timeFrame: day 14
Secondary outcomes:
measure: Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment
timeFrame: followed for 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Mary J. Laughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: