Vaccine Treatment for Advanced Malignant Melanoma

NCT00300612 | Completed Phase 1

• 2 other identifiers: NLG0104OBA#0404-640
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This 2-phase study will determine the safety of treating patients with malignant melanoma with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed melanoma cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink. Patients 18 years of age or older with malignant melanoma may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed. Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 3 months for the remaining first year (6 months) after vaccination and then every 6 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects: Medical history and physical examination Blood tests X-rays and various scans (nuclear medicine/CT/MRI) FACT-G Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, monthly during treatment, and during follow-up visits after completing the treatment. It includes questions on the severity of cancer symptoms and the ability to perform normal activities of daily life.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• To assess the side effects, dose-limiting toxicity and maximum tolerated dose.

  6 months

Secondary Outcomes (1)

• To assess tumor response and immunological response.

  6 months

Study Arms (1)

vaccine group

EXPERIMENTAL

Biological: HyperAcute-Melanoma Vaccine

Interventions

HyperAcute-Melanoma Vaccine BIOLOGICAL

Cells will be injected intradermally every two weeks for twelve vaccinations. If the patient completes all twelve vaccinations, dosage will vary from a total of 1.3 x 109 to 3.8 x 109 HyperAcute™-Melanoma Vaccine cells administered.

Also known as: HAM-1, HAM-2, and HAM-3

vaccine group

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of malignant melanoma. (pathology must be reviewed by Pathology Department)
• AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, any N, M1), metastatic, progressive, refractory, recurrent, or high risk of recurrence malignant melanoma.
• Adult patients \> or = to 18 years of age
• Measurable or non-measurable disease.
• Patient is \> or = to 4 weeks past major surgery, radiotherapy, chemotherapy. (6 weeks if treated with a nitrosureas) or biotherapy/targeted therapies and has recovered from the toxicity of prior treatment to \< or = to Grade 1, exclusive of alopecia or fatigue.
• Hemoglobin \> or = to 10.0 gm/dL, absolute granulocyte count \> or = to 1500/ mm3,platelets \> or = to 100,000/ mm3, absolute lymphocyte count \> or = to 475/ mm3.
• Total Bilirubin \< or = to 1.5 ULN (mg/dL), ALT (SGPT) and AST (SGOT) \< or = to 2.5 x ULN.
• Serum creatinine \< or = to 1.5 x ULN, or creatinine clearance \> or = to 50 mL/min.
• Serum albumin \> or = to 3.0 gm/dL.
• ECOG performance status \< or = to 2.
• All On-Study Test results are \< or = to Grade I toxicity for patient to be eligible for study, except for serum LDH. PT, PTT must be \< or = to 1.5 x ULN except for patients who are on therapeutic anticoagulant therapy.
• Negative serologies for Hepatitis B, Hepatitis C, and HIV
• Ability to give informed consent and express a willingness to meet all the expected requirements of the protocol including using contraception as outlined in the consent form.
• Expected survival \> 6 months. NOTE: Prior therapy for melanoma may include surgery, radiation therapy, immunotherapy including interleukins and interferon, and/or \< or = to 2 different chemotherapy regimens and other experimental therapies.

You may not qualify if:

• Subject has an active CNS metastases or carcinomatous meningitis. Subjects with CNS lesions that have been treated and show no evidence of progression on CT/MRI for \> or = to 3 months are eligible.
• Hypercalcemia \> 2.9 mmol/L, unresponsive to standard therapy (IV hydration, diuretics calcitonin and/or bisphosphate therapy)
• Subject is any of the following: HIV positive, history or hepatitis C virus infection, acute or chronic active hepatitis B virus infection (HbsAg positive).
• Subject has had splenectomy.
• Subject has had other malignancy within five years, and probability of recurrence of prior malignancy is \>5%. (if less than 5% subject is eligible) SEE NOTE1
• Subject has history of organ transplant or currently taking active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
• Subject is currently receiving systemic corticosteroid therapy for any reason. SEE NOTE2
• Subject has significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
• Subject has an active infection or antibiotics within 1-week prior to study,including unexplained fever (temp \> 38.1C)
• Subject has an autoimmune disease (systemic lupus erythematosis, active rheumatoid arthritis, etc.) with the exception of vitiligo. SEE NOTE3.
• Subject has a serious medical condition that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis)
• Subject has any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with an aspect of the study.
• Subject has a known allergy to a component of the alpha(1,3)galactosyltransferase tumor vaccine or cell lines from which it is derived.
• Subject is pregnant or nursing.
• NOTE1: Subjects curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or subjects with a history of malignant tumor in the past that has been disease free for at least five years are also eligible for this study.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

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

• Ronald C. DeConti, M.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Charles J. Link, M.D.

  NewLink Genetics Corporation

  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: March 7, 2006
• First Posted: March 9, 2006
• Study Start: March 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (1)