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OpenTrials
Completed

NCT Number: NCT00047021

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

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.

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Key information

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-7284, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sargramostim

Biological

Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

Cytarabine

Drug

high-dose cytarabine IV over 1 hour on days 1-5

mitoxantrone hydrochloride

Drug

high-dose mitoxantrone IV over 15-30 minutes on day 5.

Primary outcomes

  1. Event free survival at day 14 (myeloid engraftment)

    Time frame: day 14

Secondary outcomes

  1. Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment

    Time frame: followed for 3 months

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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