Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.

II. Assess response duration and progression-free intervals in these patients receiving this treatment.

OUTLINE:

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR.

Patients are followed every 9 weeks for 3 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00005949
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	March 2001

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02107755` - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma	Phase 2
Withdrawn	`NCT01216787` - RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery	Phase 2
Active, not recruiting	`NCT01026324` - Dinaciclib in Treating Patients With Stage III-IV Melanoma	Phase 1/Phase 2
Completed	`NCT01010984` - LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma	N/A
Completed	`NCT00553306` - Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma	Phase 1/Phase 2
Completed	`NCT00121225` - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma	Phase 2
Completed	`NCT00019448` - Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma	Phase 2
Active, not recruiting	`NCT03200847` - Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma	Phase 1/Phase 2
Active, not recruiting	`NCT03235245` - Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib	Phase 2
Terminated	`NCT01875653` - Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma	Phase 3
Completed	`NCT01748747` - Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery	Early Phase 1
Terminated	`NCT01316692` - Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma	Phase 2
Active, not recruiting	`NCT01120275` - Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma	Phase 2
Terminated	`NCT01026051` - Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma	Phase 2
Terminated	`NCT01217411` - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer	Phase 1
Terminated	`NCT01166126` - Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV	Phase 2
Completed	`NCT01037790` - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer	Phase 2
Completed	`NCT00288041` - Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00074308` - Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers	Phase 1/Phase 2
Completed	`NCT00072163` - Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma	Phase 2