NCT00081809

Brief Summary

Primary Objectives:

  • To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
  • the rate of complete and partial responses
  • the time to progression. Secondary Objectives:
  • To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
  • To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
  • To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
  • To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5.3 years

First QC Date

April 20, 2004

Last Update Submit

September 26, 2023

Conditions

Lymphoma, FollicularLymphoma, Small Lymphocytic

Keywords

non-Hodgkin's lymphomaBrill-Symmers DiseaseFollicular LymphomaLymphoma, Giant FollicularLymphoma, NodularFollicular Lymphoma, GiantGiant Follicular LymphomaLymphocytic Lymphoma, Diffuse, Well-DifferentiatedLymphocytic Lymphoma, Well-DifferentiatedLymphoma, Lymphocytic, Diffuse, Well-DifferentiatedLymphoma, Lymphocytic, Well-DifferentiatedLymphoma, Lymphoplasmacytoid, CLLLymphoma, Small Lymphocytic, PlasmacytoidLymphoplasmacytoid Lymphoma, CLLDiffuse Well-Differentiated Lymphocytic LymphomaLymphocytic Lymphoma, Diffuse, Well DifferentiatedLymphocytic Lymphoma, Well DifferentiatedLymphoma, Lymphocytic, Diffuse, Well DifferentiatedLymphoma, Lymphocytic, Well DifferentiatedLymphoma, Mucosa-Associated Lymphoid TissueMALT LymphomaLymphoma of Mucosa-Associated Lymphoid TissueMucosa-Associated Lymphoid Tissue LymphomaMonocytoid B-cell lymphomaWaldenstrom's macroglobulinemiaMarginal zone lymphoma

Interventions

autologous human tumor-derived HSPPC-96DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
  • Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
  • Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
  • A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
  • Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
  • Life expectancy of at least 16 weeks;
  • Zubrod performance status of less then or equal to 2;
  • Adequate bone marrow function;
  • Adequate hepatic function;
  • Adequate renal function;
  • Signed written informed consent;
  • Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator;
  • Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating;
  • Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up;
  • Electrocardiogram if none performed in the prior six months;
  • +3 more criteria

You may not qualify if:

  • Patients with active or prior history of central nervous system lymphoma;
  • Patients with serious intercurrent medical illnesses, requiring hospitalization;
  • Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
  • Women who are pregnant or lactating;
  • Patients participating in another clinical trial;
  • Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen;
  • Patients with bulky disease, defined as greater than 10 cm in diameter;
  • Patients with positive HIV antibody;
  • Patients with more than 4 previous treatment regimens will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinLymphoma, B-Cell, Marginal ZoneWaldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2004

First Posted

April 23, 2004

Study Start

March 1, 2000

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)