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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01026051
Other study ID # MKC1106-MT-002
Secondary ID
Status Terminated
Phase Phase 2
First received December 3, 2009
Last updated May 10, 2012
Start date October 2010
Est. completion date July 2012

Study information

Verified date May 2012
Source Mannkind Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanoma


Description:

The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase). The plasmid component will be administered on Days 1, 4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into non-diseased superficial inguinal lymph nodes under ultrasound guidance


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2012
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed diagnosis of regional or distant metastatic melanoma (stage IIIB, IIIC, or IV) confined to skin, subcutaneous tissue, or lymph nodes that is refractory to standard of care, or for which no curative standard therapy exists (Note: Subjects who are therapy-naïve will also be eligible.)

- Measurable disease by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria

- ECOG performance status of 0 or 1

- Life expectancy > or = 3 months

- 18 years of age or older at screening evaluation

- Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed

- Positive for HLA-A2 and, more precisely, for expression of A*0201 as assessed by DNA typing

- Tumor material from prior biopsy/surgical resection available for analysis of expression of melanoma specific antigens

- Adequate coagulation function as evidenced by prothrombin time (PT) and partial thromboplastin time (PTT) values within the normal range

- Adequate bone marrow reserve as evidenced by Absolute neutrophil count (ANC) > or = 1,000/mL; platelet count > or = 75,000/mL

- Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy, or other therapies including but not limited to chemotherapy

- Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational drug.

- Subjects who have received local radiation therapy (less than one-fourth of bone marrow) are eligible.

Exclusion Criteria:

- Subjects with visceral metastasis (Note: Subjects with stable CNS metastasis or fully treated CNS metastatic disease [eg, radiation therapy] are eligible.)

- Active infection requiring treatment

- Systemic inflammatory disease requiring chronic maintenance or suppressive therapy

- Positive antibody test result for HIV, hepatitis B, or hepatitis C

- History of allogeneic transplant

- Medical, sociological, or psychological conditions that may compromise compliance or participation or that may interfere with the interpretation of the results

- History of receiving immunosuppressive drugs within 1 month before dosing

- Subjects who are lactating, pregnant, or planning to become pregnant within 3 months of completing treatment

- Subjects who received an investigational drug within the 4 weeks before dosing

- Prior systemic radiation therapy (more than one-fourth of bone marrow)

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
MKC1106-MT
Cancer Vaccine, Immunotherapy, Melanoma

Locations

Country Name City State
United States Nevada Cancer Institute Las Vegas Nevada
United States The Angeles Clinic and Research Institute Los Angeles California
United States UCLA Medical Center Los Angeles California
United States Martin Memorial Stuart Florida

Sponsors (1)

Lead Sponsor Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria) 12 Months No
Secondary To assess clinical efficacy of MKC1106-MT in subjects with advanced melanoma measured at 6 months and 1 year by (1) time to progression, progression-free survival 12 Months No
Secondary To identify and characterize correlations between biological activity (immune response), target antigen expression and clinical efficacy. 12 months No
Secondary To further assess the safety profile and tolerability 12 months No
See also
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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
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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 NCT01166126 - Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
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
Completed NCT00026143 - Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma Phase 2