Study of gp75 Vaccine in Patients With Stage III and IV Melanoma

NCT00034554 | Completed Phase 1

• 1 other identifier: CP09-0001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies.

Conditions

Malignant Melanoma

Keywords

AJCC stage III or stage IV malignant melanoma; melanoma; gp75; DNA vaccine

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and feasibility of intramuscular vaccination with gp75 DNA in patients with stage III or IV melanoma.

Secondary Outcomes (2)

• Observe patients for any evidence of anti-tumor response, which is generated after vaccination.

• Establish the optimal biologically effective dose, defined as the lowest dose that correlates the production of anti-gp75 antibodies.

Study Arms (5)

1

EXPERIMENTAL

0.1mg

Biological: gp75 DNA vaccine

2

EXPERIMENTAL

0.5mg

Biological: gp75 DNA vaccine

3

EXPERIMENTAL

2.0mg

Biological: gp75 DNA vaccine

4

EXPERIMENTAL

4.0mg

Biological: gp75 DNA vaccine

5

EXPERIMENTAL

8.0mg

Biological: gp75 DNA vaccine

Interventions

gp75 DNA vaccine BIOLOGICAL

6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5\* patient safely completing the 2nd vaccination at the lower dose level.

1; 2; 3; 4; 5

Eligibility Criteria

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

You may qualify if:

• The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor \>4 rnm, satellite or in-transit lesions, one or more positive lymph nodes or distant metastases) for recurrence is also eligible. A patient with metastatic disease may have no more than five sites of disease. The skin represents one site regardless of the number of lesions. Stage 111 melanoma is defined as a pT4 primary tumor (\>4m in depth or Clark level 5) in-transit metastases, satellites lesions or regional lymph nodes involved with melanoma.Pathology slides must be reviewed by the investigational site's Department of Pathology.
• The patient's Karnofsky performance status is 280 at study entry.
• The patient has given signed informed consent.
• The patient has had surgery for their melanoma at least 6 months prior to study entry, or has had prior interferon therapy, or developed unacceptable toxicities to interferon therapy, or has a pre-existing condition(s) that precludes the patient fkom receiving interferon treatment.
• The patient is 21 8 years of age.
• The patient must have completed any prior irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) at least 30 days prior to study entry.
• The patient has adequate hematologic function as defined as a platelet count 2100,000/mm3 and white blood cell (WBC) level 23,000/mm3.
• The patient has serum lactose dehydrogenase (LDH) within normal range and a serum creatinine level \<2.0 mg/dL.
• The patient agrees to use effective contraception if procreative potential exists.

You may not qualify if:

• The patient has stage I11 disease otherwise eligible to receive standard of care melanoma therapy.
• The patient has a medical condition or use of medication (eg, corticosteroids) that might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them, in the opinion of the investigator.
• The patient has received irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) within 30 days prior to study entry.
• The patient is pregnant (confirmed by serum beta human chorionic gonadotropin \[PHCG\], if applicable) or is breast feeding.
• The patient has received any investigational agents within 30 days of study entry.
• The patient has received prior cancer vaccine therapy.
• The patient has evidence of central nervous system (CNS) metastasis.
• The patient has evidence of an ocular abnormality, as detected by a slit-lamp ophthalmologic examination, within 4 weeks prior to study entry.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

ImClone Investigational Site

New York, New York, 10021, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Melanoma

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

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

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: April 30, 2002
• First Posted: May 1, 2002
• Study Start: March 1, 2002
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: April 9, 2010

Record last verified: 2009-12

Locations

US (1)