Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

NCT00005802 | Completed Phase 1

• 4 other identifiers: 1380.00FHCRC-1380.00NCI-H00-0057CDR0000067777
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia.

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; 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)

Interventions

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

therapeutic allogeneic lymphocytes BIOLOGICAL

cytarabine DRUG

etoposide DRUG

fludarabine phosphate DRUG

methotrexate DRUG

mitoxantrone hydrochloride DRUG

therapeutic hydrocortisone DRUG

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following: * Morphologic relapse defined as 1 or more of the following: * Peripheral blasts in absence of growth factor therapy * Bone marrow blasts greater than 5% of nucleated cells * Extramedullary (CNS, testicular, or other sites) * Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant * Cytogenetic relapse defined as: * Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR * New abnormality known to be associated with leukemia * Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor * Must have achieved complete remission after PBSCT * Current donor must be same as prior donor * Age 10 and over PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * SWOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No congestive heart failure requiring diuretics * No uncontrolled arrhythmia Pulmonary: * No pulmonary dysfunction requiring oxygen therapy * No pneumonia or severe obstruction * FEV\_1 at least 50% of predicted OR no greater than 50% decline from baseline * No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia Other: * No sepsis, aspergillosis, or other active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent cyclosporine or tacrolimus during induction chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

• Clark JA, Turner ML, Howard L, Stanescu H, Kleta R, Kopp JB. Description of familial keloids in five pedigrees: evidence for autosomal dominant inheritance and phenotypic heterogeneity. BMC Dermatol. 2009 Jul 28;9:8. doi: 10.1186/1471-5945-9-8.

  PMID: 19638218 DERIVED

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Congenital Abnormalities

Interventions

aldesleukin; Filgrastim; Cytarabine; Etoposide; fludarabine phosphate; Methotrexate; Mitoxantrone; Hydrocortisone; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Therapeutics

Study Officials

• Mary E. D. Flowers, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: June 1, 1999
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: April 2, 2010

Record last verified: 2010-03

Locations

US (1)