Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

NCT01883518 | Unknown Phase 1

• 1 other identifier: MC-01-2013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas

Conditions

Sarcoma; Neoplasms, Connective and Soft Tissue

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

  6 month

Secondary Outcomes (4)

• Median progression-free survival

  6 month

• Median overall survival

  6 month

• Objective response rate

  6 mounth

• Assess biological response of tumors

  6 mounth

Study Arms (1)

Autologous dendritic cell vaccine

EXPERIMENTAL

Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens

Biological: Autologous dendritic cell vaccine

Interventions

Autologous dendritic cell vaccine BIOLOGICAL

Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens

Also known as: Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens, CTA vaccine, DC vaccine, DC CTA vaccine

Autologous dendritic cell vaccine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Untreated or uncontrolled brain metastases.
• History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
• 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.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

N. N. Petrov Research Institute of oncology

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Sarcoma; Neoplasms, Connective and Soft Tissue; Fibrosarcoma; Neurofibrosarcoma; Histiocytoma; Histiocytoma, Malignant Fibrous; Chondrosarcoma; Sarcoma, Synovial; Leiomyosarcoma; Liposarcoma; Myosarcoma; Rhabdomyosarcoma; Sarcoma, Alveolar Soft Part

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue

Study Officials

• Yuriy Komarov, PhD

  N. N. Petrov Research Institute of oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

RU (1)