Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

NCT00053105 | Unknown Phase 1

• 5 other identifiers: CDR0000269140THERADEX-AZA-I-05NOVUSPHARMA-AZA-I-05NOVUSPHARMA-AZA-1401CWRU-050213J
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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 effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma; recurrent grade 3 follicular lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma

Interventions

cisplatin DRUG

cytarabine DRUG

methylprednisolone DRUG

pixantrone dimaleate DRUG

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following: * Diffuse large B-cell lymphoma * Transformed NHL * Follicular large cell lymphoma * Peripheral T-cell lymphoma * Unclassified aggressive histology (immunoblastic lymphoma) * Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m\^2) * No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age * 18 to 64 Performance status * WHO 0-1 Life expectancy * At least 3 months Hematopoietic * Neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* NOTE: \*Lower values may be accepted if evidence of bone marrow involvement Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*\* * Alkaline phosphatase no greater than 2 times ULN\*\* * AST or ALT no greater than 2 times ULN\*\* * No history or clinical symptoms of hepatitis B or C virus NOTE: \*\*Higher values may be accepted if evidence of liver involvement Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * LVEF at least 50% by MUGA * No clinically significant cardiovascular abnormalities * No New York Heart Association class II-IV heart disease * No myocardial infarction within the past 6 months * No severe arrhythmia * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study * No history or clinical symptoms of HIV * No clinically significant neurological abnormalities * No serious uncontrolled infection (NCI CTC grade 3-4) * No condition that would place the patient at undue risk or interfere with the study results PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior radioimmunotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 1 year since prior platinum or cytarabine (unless complete response to treatment) * At least 2 years since prior fludarabine or nitrosoureas * No prior cumulative cisplatin greater than 600 mg/m\^2 Endocrine therapy * Not specified Radiotherapy * See Biologic therapy * At least 4 weeks since prior radiotherapy * No prior radiotherapy to the whole pelvis Surgery * At least 1 week since prior minor surgery and recovered * At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered Other * At least 1 month since prior investigational drugs * Recovered from prior therapy * No other concurrent investigational drugs

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

Sponsors & Collaborators

• Theradex: lead

Study Sites (7)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0800, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

Boston Baskin Cancer Group, University Tennessee

Memphis, Tennessee, 38104, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, T-Cell, Cutaneous; Lymphoma, Large-Cell, Immunoblastic

Interventions

Cisplatin; Cytarabine; Methylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luis Fayad, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: February 1, 2002
• Last Updated: July 7, 2009

Record last verified: 2003-03

Locations

US (7)