Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00036426
Other study ID # FavId-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received May 9, 2002
Last updated June 23, 2005
Start date March 2001

Study information

Verified date October 2004
Source Favrille
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.


Description:

The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.


Other known NCT identifiers
  • NCT00014157

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

- 18 years of age

- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)

- Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease.

- Tumor accessible for biopsy or previously existing biopsy material

- At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension

- Performance status (ECOG) of 0, 1 or 2

- Absolute Granulocyte count ? 1,000/mm3

- Total Bilirubin < 2 mg/dL

- AST and ALT < 2x Upper Limit of Normal

- Creatinine < 1.5 mg/dL

Exclusion Criteria

- Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens

- Prior fludarabine

- Prior tumor-specific idiotype immunotherapy

- Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment

- Concurrent immunosuppressive therapy (high-dose steroids; etc)

- Prior splenectomy

- Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination

- Known history of CNS lymphoma or meningeal lymphomatosis

- HIV positive

- Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives

- Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years

- Treatment with an investigational drug within 30 days prior to study entry

- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
FavId (Id-KLH) active immunotherapy


Locations

Country Name City State
United States New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center Bronx New York
United States Northwestern University Chicago Illinois
United States Oncology Hematology Care, Inc. Cincinnati Ohio
United States Henry Ford Hospital Detroit Michigan
United States University of Florida, Jacksonville Jacksonville Florida
United States Scripps Stevens Cancer Center La Jolla California
United States University of California San Diego La Jolla California
United States Tower Hematology Oncology Medical Group Los Angeles California
United States New York Hospital - Cornell Medical Center New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Oncology Associates of San Diego San Diego California
United States Medical Group of North County Vista California

Sponsors (1)

Lead Sponsor Collaborator
Favrille

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00317096 - FCM Versus R-FCM Followed by R-Maintenance or Observation Only Phase 3
Completed NCT00051025 - Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL) Phase 2
Not yet recruiting NCT03910283 - Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer N/A
Terminated NCT00143884 - Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood Phase 2
Completed NCT00536458 - Treatment of Localized Low Grade Lymphomas Phase 3
Withdrawn NCT01263418 - Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas Phase 2
Completed NCT00168727 - Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma Phase 4
Completed NCT00546793 - Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL Phase 1/Phase 2
Terminated NCT00060671 - Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma Phase 3
Completed NCT00311129 - Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL Phase 2
Completed NCT00060684 - Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma Phase 1
Active, not recruiting NCT01181271 - Tandem Auto-Allo Transplant for Lymphoma Phase 2
Completed NCT00220285 - Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma Phase 2
Terminated NCT00038883 - Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies N/A
Completed NCT00143845 - Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant Phase 2