Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

NCT00003217 | Completed Phase 1 DMC

• 3 other identifiers: 9517POG-9517CDR0000066078
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 14

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 I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkin's lymphoma or acute lymphoblastic leukemia.

Conditions

Leukemia; Lymphoma

Keywords

childhood Burkitt lymphoma; untreated childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia; stage III childhood small noncleaved cell lymphoma; stage IV childhood small noncleaved cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

Study Arms (1)

Treatment

EXPERIMENTAL

See detailed description.

Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: methotrexate; Drug: vincristine sulfate

Interventions

filgrastim BIOLOGICAL

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Treatment

cyclophosphamide DRUG

Also known as: CTX, Cytoxan, NSC #26271, IND #7089

Treatment

cytarabine DRUG

Also known as: cytosine arabinoside, Ara-C, Cytosar, NSC #63878

Treatment

dexamethasone DRUG

Also known as: Decadron, NSC #034521

Treatment

doxorubicin hydrochloride DRUG

Also known as: Adriamycin, NSC #123127, IND #7038

Treatment

methotrexate DRUG

Also known as: MTX, amethopterin, NSC #740, IND #4291

Treatment

vincristine sulfate DRUG

Also known as: VCR, Oncovin, NSC #67574, IND #7161

Treatment

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Cytologically proven small, noncleaved cell non-Hodgkin's lymphoma, Burkitt's lymphoma, non-Burkitt's lymphoma, or B cell acute lymphoblastic leukemia (B-ALL) Stage III or IV B-ALL - must have FAB L3 morphology and have been registered on POG-9400 PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV antibody positive allowed Not pregnant or lactating PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior emergency steroid therapy may be allowed Radiotherapy: Prior emergency radiotherapy may be allowed Surgery: Prior surgery allowed Other: No concurrent dexamethasone as an anti-emetic

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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (14)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Burkitt Lymphoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Cyclophosphamide; Cytarabine; Dexamethasone; Calcium Dobesilate; Doxorubicin; Methotrexate; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Timothy C. Griffin, MD

  Cook Children's Medical Center - Fort Worth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 6, 2004
• Study Start: March 1, 1998
• Primary Completion: October 1, 2004
• Study Completion: September 1, 2006
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

US (12); CA (2)