Autologous T-Cell Transplantation and the Immunotherapy of Residual Disease in Breast Cancer: Pilot Study of Vaccine-Driven T-Cell Expansion in Patients Treated With Dose-Intensive Chemotherapy

NCT00001440 | Completed Phase 1

• 2 other identifiers: 95014695-C-0146
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug resistant residual tumor cells remaining after chemotherapy that generally result in relapse. Additional therapeutic strategies to eradicate these residual tumor cells are needed. The augmentation of specific anti-tumor immune responses, such as those mediated by T-cells, might represent such an additional strategy for the control or elimination of residual tumor cells. This approach might be especially effective if T-cell mediated responses were enhanced during both the period of T-cell repopulation that follows acute T-cell depletion and in the setting of minimal residual tumor burden present after dose intensive chemotherapy. Such chemotherapy is known to result in severe T-cell depletion. This pilot study has been designed to examine the feasibility of combining dose intensive chemotherapy with interventions aimed at the reconstitution of T-cell immunity. Metastatic or adjuvant breast cancer patients who have received dose intensive chemotherapy will subsequently receive a combination of autologous chemotherapy-naive T-cells, a patient-specific tumor antigen vaccine, and recombinant human interleukin-2. These interventions will be assessed for their ability to modulate T-cell number, T-cell function, and T-cell specificity during the period of T-cell repopulation. Such modulation may result in the effective reconstitution of generalized T-cell immunity with the generation of vaccine-specific anti-tumor T-cell responses.

Conditions

Breast Neoplasm; Neoplasm Metastasis

Keywords

p53; Interleukin-2; T-Cell Repopulation; Apheresis; RAS

Interventions

Autologous T cells PROCEDURE

Interleukin-2 DRUG

Eligibility Criteria

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

You may not qualify if:

• Patients must not present with any unusual medical or psychiatric risk.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Henderson IC, Hayes DF, Gelman R. Dose-response in the treatment of breast cancer: a critical review. J Clin Oncol. 1988 Sep;6(9):1501-15. doi: 10.1200/JCO.1988.6.9.1501.

  PMID: 3047340 BACKGROUND

• Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.

  PMID: 7919339 BACKGROUND

• Mackall CL, Fleisher TA, Brown MR, Andrich MP, Chen CC, Feuerstein IM, Horowitz ME, Magrath IT, Shad AT, Steinberg SM, et al. Age, thymopoiesis, and CD4+ T-lymphocyte regeneration after intensive chemotherapy. N Engl J Med. 1995 Jan 19;332(3):143-9. doi: 10.1056/NEJM199501193320303.

  PMID: 7800006 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: November 4, 1999
• Study Start: July 1, 1995
• Study Completion: January 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-01

Locations

US (1)