Status:
COMPLETED
Phase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
University of Maryland, College Park
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is: 1. To evaluate the safety of activated T cell infusions and immunization with hTERT multi-peptide vaccine in the post-transplant setting and whether the combination can ...
Detailed Description
This protocol proposes to combine two different investigational products to test the hypothesis that autologous T cell therapy can augment the potency of a putative tumor vaccine post- stem cell trans...
Eligibility Criteria
Inclusion
- Each subject must meet ALL of the following criteria during screening to be enrolled in the study:
- Written informed consent must be obtained from all patients before entry into the study
- Patients must have a diagnosis of myeloma
- Patients must meet one of the following criteria:
- Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy.
- Myeloma has responded partially to initial therapy but neither a complete nor a near-complete response has developed after at least 3 cycles or months of initial therapy.
- Myeloma has high-risk features
- Patients must have measurable disease on study entry.
- Patients must be between ages 18-80 (inclusive).
- Patients should have adequate vital organ function.
- ECOG performance status 0-2
- Women of child-bearing potential (WOCBP) and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study and for at least 4 months after the last dose of chemotherapy. In addition, contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the STEPS program.
- Key Exclusion Criteria
- Subjects who meet ANY of the following criteria cannot be enrolled in the study:
- Pregnant or nursing females
- HIV, HTLV-1/2 seropositivity
- Known history of myelodysplasia
- Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
- Active Hepatitis B
- Prior autotransplant or allogeneic transplant
- More than 4 distinct, prior courses of therapy for myeloma
- History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
- Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
- Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study
- Active bacterial, viral or fungal infections.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00834665
Start Date
December 1 2006
End Date
December 1 2017
Last Update
October 23 2019
Active Locations (2)
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1
Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104