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A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)


OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein
peptide vaccine in terms of the rate of complete and partial response and time to
progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and
tolerability of this treatment regimen in this patient population. III. Determine the
anti-tumor response to this treatment regimen in these patients.

OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor
cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients
receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of
disease progression or unacceptable toxicity. Patients with improving or stable disease or
without recurrence continue on therapy for up to 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent soft tissue sarcoma
Incompletely or completely resected metastatic or locally recurrent disease (surgery must
be performed with intent of complete resection) No active brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life
expectancy: At least 16 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,000/mm3 Platelet count at least 80,000/mm3 Hepatic: Not specified Renal:
Creatinine no greater than 2.5 mg/dL Cardiovascular: No New York Heart Association class
III or IV heart disease Other: No active infections requiring antibiotics within 2 weeks
of study No other serious medical illness requiring hospitalization No history of primary
or secondary immunodeficiency or autoimmune disease No contraindications to MRI (e.g.,
aneurysm clips or cardiac pacemakers) Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and
recovered Chemotherapy: At least 6 weeks since prior chemotherapy and recovered Endocrine
therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 weeks since prior
radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy
Other: At least 6 weeks since other prior experimental anticancer therapy and recovered No
concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs No other
concurrent participation in a clinical trial

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-077

NCT ID:

NCT00005628

Start Date:

November 1999

Completion Date:

August 2001

Related Keywords:

  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021