Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma

NCT00983944 | Withdrawn Phase 2 DMC

• 2 other identifiers: OSU-08178NCI-2011-03123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating large B-cell lymphoma. PURPOSE: This randomized phase II trial is studying how well rituximab and combination chemotherapy work when given with or without bleomycin sulfate in treating patients with primary mediastinal large B-cell lymphoma.

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; childhood diffuse large cell lymphoma; stage I childhood large cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Up to a year

Secondary Outcomes (5)

• Two-year progression-free survival

  Up to 2 years

• Overall survival

  Up to 3 years

• Toxicity as assessed by NCI CTCAE v3.0

  Up to 3 years

• Immunohistochemical staining results

  Up to a year

• Correlation of soluble CD30 levels with disease activity in PMLCL

  Up to a year

Study Arms (2)

Arm I (EPOCH-R)

EXPERIMENTAL

Patients receive rituximab IV on day 1; etoposide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 30 minutes on day 5; and oral prednisone twice daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: rituximab; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate

Arm II (R-VACOP-B)

EXPERIMENTAL

Patients receive rituximab IV and doxorubicin hydrochloride IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; cyclophosphamide IV over 30 minutes on day 1 of weeks 1, 5, and 9; etoposide IV over 1 hour on day 1 and then orally on days 2 and 3 of weeks 3, 7, and 11; bleomycin sulfate IV and vincristine sulfate IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; and oral prednisone on days 1-7 of week 1 and then every other day in weeks 2-10.

Biological: bleomycin sulfate; Biological: rituximab; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate

Interventions

bleomycin sulfate BIOLOGICAL

Given IV

Arm II (R-VACOP-B)

rituximab BIOLOGICAL

Given IV

Arm I (EPOCH-R); Arm II (R-VACOP-B)

EPOCH regimen DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

cyclophosphamide DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

doxorubicin hydrochloride DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

etoposide DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

prednisone DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

vincristine sulfate DRUG

Given IV or orally

Arm I (EPOCH-R); Arm II (R-VACOP-B)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary mediastinal (thymic) large B-cell lymphoma as defined by WHO classification of lymphoid neoplasms * Diagnosis must be based on an adequate tissue sample, such as an excisional biopsy or core-needle biopsy * A paraffin-embedded block of well-fixed lymphoma tissue must be available * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm * No active or untreated CNS lymphoma * A lumbar puncture is not required in the absence of neurologic symptoms PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,000/mm\^3 (unless related to disease) * Platelet count ≥ 100,000/mm\^3 (unless related to disease) * Total bilirubin ≤ 2.0 times upper limit of normal (ULN) * AST and/or ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Ejection fraction ≥ 45% by MUGA or echocardiogram * Patients with HIV infection are eligible, provided the following criteria are met: * No evidence of co-infection with hepatitis B or C * CD4 cell count ≥ 400/mm\^3 * No evidence of resistant strains of HIV * HIV viral load ≤ 10,000 copies HIV RNA/mL (if not on anti-HIV therapy) * HIV viral load ≤ 50 copies HIV RNA/mL (if on anti-HIV therapy) * No history of AIDS-defining conditions * No concurrent uncontrolled illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situation that would limit compliance with study requirements * No active secondary malignancy except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: * No prior cytotoxic chemotherapy or rituximab * Prior limited course of glucocorticoids allowed * No other concurrent investigational or commercial anticancer therapies

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating

Interventions

Bleomycin; Rituximab; EPOCH protocol; Cyclophosphamide; Doxorubicin; Etoposide; Prednisone; Vincristine

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; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Kristie A. Blum, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: April 25, 2011
• Study Completion: April 25, 2011
• Last Updated: November 30, 2017

Record last verified: 2017-11