Safety Study of CADI-05 in Patients With Advanced Stage Melanoma

NCT00675727 | Terminated Phase 1 DMC

• 1 other identifier: CR-60/4051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected.

Conditions

Stage III or Stage IV Melanoma

Keywords

Melanoma; Mycobacterium w

Outcome Measures

Primary Outcomes (1)

• Recording of any clinical adverse reactions at anytime during the study for assessment of safety.

  6-24 months

Secondary Outcomes (1)

• Both physical examinations and imaging studies will be used to evaluate clinical response to CADI-05 treatment.

  6-24 months

Interventions

CADI-05 BIOLOGICAL

Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks.

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Ability to understand and the willingness to sign a written informed consent document
• Subject must have a pathologic diagnosis malignant melanoma (stage III or IV).
• Subject must have at least one of the following:
• Melanoma that was previously treated with at least one complete or partial course of therapy for melanoma with either a poor to no response or evidence of disease progression;
• Melanoma that cannot be treated with first-line therapies because of medical comorbidities/risk of toxicity; or
• Melanoma that has not been treated with first-line therapies because of patient refusal.
• If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection.
• The subject must have measurable disease, as defined by the presence of at least one measurable lesion, defined as having longest diameter greater than or equal to 20 mm by conventional measurement techniques (e.g., measurement of evaluable cutaneous metastases) or greater than or equal to 20 mm by imaging studies.
• Subject must have an ECOG performance status of 0, 1, or 2.
• Subject must have the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines. Alternatively, if the subject is mentally incompetent for medical decision-making, a parent, legal guardian, or power of attorney has the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines.
• Subject must be able to comply with office visits as required by the protocol.
• The effects of Investigational product on the developing human fetus is at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Subjects with medical co-morbidities, which in the judgment of the investigator, place them at an unacceptable level of risk for participation in this study.
• Pregnant women, since the prenatal effects of CADI-05 have not been characterized.
• Subjects with HIV, AIDS, or chronic immunosuppression for organ transplantation.
• Subjects who are unable to comply with office visits as required by this protocol or would suffer great hardship by participating in the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
• Clinically significant active infection.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (1)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Immuvac

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paul J Mosca, M.D., Ph.D.

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2010
• Last Updated: June 11, 2009

Record last verified: 2009-06

Locations

US (1)