Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma

NCT00134082 | Completed Phase 1 Results

• 4 other identifiers: J0528P50CA096888P30CA006973NA_00035358
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 3-5 Adverse Events

  Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.

  Up to 36 months

• Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells

  Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement.

  Change from 3 months to 6 months

Secondary Outcomes (2)

• Survival

  Up to 6 years

• Days to Neutrophil and Platelet Engraftment

  Up to 46 days

Study Arms (1)

Immunotherapy

EXPERIMENTAL

All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.

Biological: KGEL vaccine; Biological: Filgrastim; Biological: Rituximab; Drug: Cyclophosphamide

Interventions

KGEL vaccine BIOLOGICAL

Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.

Immunotherapy

Filgrastim BIOLOGICAL

5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.

Also known as: G-CSF

Immunotherapy

Rituximab BIOLOGICAL

375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.

Also known as: Rituxan

Immunotherapy

Cyclophosphamide DRUG

50 mg/kg/day on Day -3, -2, -1, and 0.

Also known as: Cytoxan

Immunotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed classical Hodgkin's lymphoma * Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy * No primary induction failure, defined as disease progression during or within 2 months after completion of first-line therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL\* NOTE: \*Unless due to lymphoma or Gilbert's syndrome Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Ejection fraction ≥ 45% by echocardiogram or MUGA Pulmonary * DLCO ≥ 50% of predicted (corrected for alveolar volume) Immunologic * No known HIV positivity * No active infection requiring oral or IV antibiotics * No autoimmune or other disease requiring long-term systemic steroids or other long-term immunosuppressants Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to tolerate high-dose therapy * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior bone marrow transplantation Endocrine therapy * Not specified Radiotherapy * Concurrent radiotherapy for disease progression after high-dose cyclophosphamide allowed at the discretion of the principal investigator Surgery * Not specified

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Rituximab; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Richard Ambinder, MD
• Organization: Johns Hopkins University

rambind1@jhmi.edu

4109558839

Study Officials

• Richard Ambinder, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)