Vaccine Treatment for Advanced Malignant Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00300612
• Date of registration: 07/03/2006
• Primary sponsor: NewLink Genetics Corporation
• Public title: Vaccine Treatment for Advanced Malignant Melanoma
• Scientific title: A Phase I/II Study of an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Malignant Melanoma
• Date of first enrolment: March 2006
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00300612
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Charles J. Link, M.D.
• Affiliation: NewLink Genetics Corporation

• Name: Ronald C. DeConti, M.D.
• Affiliation: University of South Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

NOTE2: Subject's receiving inhaled or topical corticosteroids are eligible. Subjects who
require systemic corticosteroid therapy after beginning vaccination will be removed from
the study.

NOTE3: Subjects with a remote history of asthma or mild active asthma are eligible.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant Melanoma

Intervention(s)

Biological: HyperAcute-Melanoma Vaccine

Primary Outcome(s)

To assess the side effects, dose-limiting toxicity and maximum tolerated dose. [Time Frame: 6 months]

Secondary Outcome(s)

To assess tumor response and immunological response. [Time Frame: 6 months]

Secondary ID(s)

NLG0104

OBA#0404-640

Source(s) of Monetary Support

Please refer to primary and secondary sponsors