Trials / Terminated
TerminatedNCT01744171
Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma
A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. SECONDARY OBJECTIVES: I. To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on measurable clinical tumor. II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine. III. To determine the effect of dose and serial administration of the chaperone complex vaccine on cell mediated and humoral immune responses. IV. To quantify patient characteristics (human leukocyte antigen \[HLA\] subtype, immune cell function, etc.) that may correlate with immune response to the chaperone complex vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant hsp110-gp100 chaperone complex vaccine intradermally (ID) on days 1, 15, and 43 in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine | Given ID |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2013-03-26
- Primary completion
- 2018-06-11
- Completion
- 2018-06-11
- First posted
- 2012-12-06
- Last updated
- 2022-07-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01744171. Inclusion in this directory is not an endorsement.