GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

NCT00324831 | Suspended Phase 3

• 3 other identifiers: CDR0000466677FAV-ID-11FAV-WIRB-20051774
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF together with vaccine therapy is more effective than giving GM-CSF together with a placebo when given after combination chemotherapy and rituximab in treating diffuse large B-cell lymphoma. PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how well they work compared to GM-CSF and placebo when given after combination chemotherapy and rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival as measured by the Kaplan-Meier method at 3 years

Secondary Outcomes (3)

• Disease-free survival as measured by the Kaplan-Meier method at 2 years

• Duration of response (complete or partial response)

• Overall disease-free survival

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

rituximab DRUG

sargramostim DRUG

vincristine DRUG

Intervention/procedure PROCEDURE

antibody therapy PROCEDURE

biological therapy PROCEDURE

chemotherapy PROCEDURE

colony-stimulating factor therapy PROCEDURE

cytokine therapy PROCEDURE

monoclonal antibody therapy PROCEDURE

non-specific immune-modulator therapy PROCEDURE

therapeutic procedure PROCEDURE

tumor cell derivative vaccine PROCEDURE

vaccine therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell lymphoma * Bulky stage II or stage III or IV disease * Treatment naïve * International Prognostic Index score of 3 (high-intermediate) or 4/5 (high) * Lymphoma accessible for sampling or existing biopsy material judged suitable for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®) * No history of CNS lymphoma or meningeal lymphomatosis * No history of indolent lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Platelet count \> 75,000/mm\^3 * ALT and AST \< 2 times upper limit of normal * Not pregnant or nursing * No history of unresolved hepatitis B viral infection * No history of a treated prior malignancy unless in remission ≥ 2 years, except for treated nonmelanoma carcinomas of the skin or in situ cervical carcinomas or prostatic carcinomas * No contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on ECG) * No contraindication to vincristine (e.g., peripheral neuropathy) * No know HIV positivity * No serious nonmalignant disease, including any of the following: * Psychiatric disorders * Compromised pulmonary function * Congestive heart failure * Active bacterial, viral, or fungal infections PRIOR CONCURRENT THERAPY: * No prior keyhole limpet hemocyanin * No planned radiotherapy during or after study therapy * No concurrent systemic immunosuppressive therapy (e.g., steroids)

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

Sponsors & Collaborators

• Favrille: lead

Study Sites (2)

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; sargramostim; Vincristine; Methods; Immunization, Passive; Biological Therapy; Drug Therapy; Antibodies, Monoclonal; Coal Tar; Immunotherapy, Active

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

Intervention Hierarchy (Ancestors)

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; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Investigative Techniques; Immunization; Immunotherapy; Immunomodulation; Therapeutics; Immunologic Techniques; Tars; Complex Mixtures

Study Officials

• John F. Bender, PharmD

  Favrille

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 11, 2006
• Last Updated: December 18, 2013

Record last verified: 2007-03

Locations

US (2)