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Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma, Neoplasms, Connective and Soft Tissue

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Trial Information

Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma


Inclusion Criteria:



- age of 18 or older

- ECOG performance score 0 or 1

- Histologically proven soft tissue sarcoma

- Unresectable or metastatic soft tissue sarcoma

- Ability to give written informed consent

- Objective measured and measurable tumor lesions

- The failure of standard therapy

- Adequate amount of material for genetic research

- No active or chronic infection with HIV, Hepatitis B or Hepatitis C

- Men/Women of childbearing potential must use adequate contraception

- Hematology, liver function and renal function lab tests within required parameters

Exclusion Criteria:

- Untreated or uncontrolled brain metastases.

- History of other active malignancy within last 2 years, except adequately treated
other soft tissue sarcoma.

- Autoimmune disease (vitiligo is not a basis for exclusion).

- Serious uncontrolled medical disorder or active infection that would impede
treatment.

- Underlying medical or psychiatric condition that would cause administration vaccine

- Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine

- Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or
cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration;
other investigational therapies; chronic use of systemic corticosteroids (however, a
low stable dose steroid for mild brain edema or adrenal insufficiency is allowed;
topical and inhaled standard dose corticosteroids are allowed).

- Dementia or significantly altered mental status that would prohibit understanding or
rendering of informed consent and compliance with protocol requirements.

- Pregnant or breastfeeding women.

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g. infectious) illness.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas

Outcome Description:

Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas

Outcome Time Frame:

6 month

Safety Issue:

No

Authority:

Russia: Ethics Committee

Study ID:

MC-01-2013

NCT ID:

NCT01883518

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Fibrosarcoma
  • Neurofibrosarcoma
  • Histiocytoma
  • Histiocytoma, Malignant Fibrous
  • Chondrosarcoma
  • Synovial Sarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Myosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Alveolar Soft Part
  • NY-ESO-1
  • MAGE
  • MAGE A3
  • Vaccine
  • Immunotherapy
  • Neoplasms
  • Testicular Neoplasms
  • Neoplasms, Connective and Soft Tissue
  • Sarcoma

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