M-Vax + Low Dose Interleukin-2 Versus Placebo Vaccine in Metastatic Melanoma in Patients With Stage IV Melanoma

NCT00477906 | Unknown Phase 3

• 1 other identifier: A/100/0402
• Study Type: interventional
• Target: 387
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous studies suggests that M-Vax, a melanoma vaccine prepared from patients own cancer cells, can stimulated patients' immune system to react against their cancer. AVAX has identified a dose and schedule of administration of M-Vax that work optimally. In this study, AVAX will determine whether M-Vax is effective in shrinkage of melanomas that have spread (stage IV). To increase it effectiveness, M-Vax administration will be followed by administration of low doses of interleukin-2 (IL2), a marketed drug that is known to stimulate immunity and cause some shrinkage of melanomas. Two-thirds of patients will receive M-Vax + IL2, and one-third will receive a placebo vaccine + IL2. The study is blinded so that neither the patients nor their physicians know which material they are receiving. To be eligible for this study, patients must have at least one melanoma tumor that can be surgically removed and made into a vaccine. In addition, they must have melanoma that has spread to to the lungs or to soft tissue sites (under the skin, on the surface of the skin, lymph nodes). Eligible patients may have previously received one treatment (for example, chemotherapy) for their melanoma. Side effects of M-Vax are expected to be mild; the most common is the development of sore pimples at the site of vaccine injections. The low dose IL2 may cause some fatigue and other mild symptoms. It is expected that 387 patients will be treated in this study.

Conditions

Melanoma

Keywords

melanoma; vaccine; metastatic; autologous

Outcome Measures

Primary Outcomes (2)

• Best overall anti-tumor response.

  1 year

• Survival - % patients surviving at two years

  2 years

Secondary Outcomes (1)

• Safety

  5 years

Study Arms (2)

1

EXPERIMENTAL

MVax + BCG + cyclophosphamide + IL2 2:1 randomization - MVax:Control

Biological: M-Vax- autologous, hapten-modified melanoma vaccine

2

PLACEBO COMPARATOR

Placebo Vaccine + BCG + cyclophosphamide + IL2

Biological: M-Vax- autologous, hapten-modified melanoma vaccine

Interventions

M-Vax- autologous, hapten-modified melanoma vaccine BIOLOGICAL

Autologous, DNP-modified melanoma cells in suspension Dose: 12+-8 million cells Route: intradermal Frequency: weekly X7 + 6 month booster

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV metastatic melanoma of cutaneous or mucosal origin or without known primary site
• At least one metastatic mass that is surgically resectable, excluding metastases in brain, bowel, or bone
• Successful preparation of a vaccine that meets quality control release criteria
• Following surgery for vaccine preparation, subjects must have at least one measurable metastasis defined by modified RECIST criteria. Non-measurable metastases may also be present. Residual metastases (measurable or non-measurable) must be limited to skin (dermal or subcutaneous), lymph node, or lung, or a combination of these.
• No prior systemic treatment or one prior systemic treatment for metastatic melanoma, not counting post-surgical adjuvant treatment with alpha interferon
• Minimum of one month and maximum of 4 months since the surgery
• Expected survival of at least 6 months
• Karnofsky performance status at least 80
• Signed informed consent

You may not qualify if:

• Failure to prepare a vaccine that meets all quality control release criteria
• Uveal melanoma
• Post-surgical residual metastases in sites other than specified in 6.1
• Brain metastases, current or past (unless successfully treated at least one year prior to enrollment)
• Hepatic transaminase \> 2.5 x ULN
• Total bilirubin \> 2.0 mg/Dl
• Creatinine \> 2.0 mg/Dl
• Hemoglobin \< 10.0 g/Dl
• WBC \< 3,000 /mm3
• Platelet count \< 100,000/mm3
• Limited field radiotherapy, i.e., limited to recent surgical site, less than 4 weeks prior to first dose of vaccine
• Major field radiotherapy less than 6 months prior to first dose of vaccine
• Any systemic treatment for metastatic melanoma, including chemotherapy, cytokines, or investigational drugs less than 2 months prior to first dose of vaccine
• Previous administration of M-Vax
• Prior splenectomy

Sponsors & Collaborators

• AVAX Technologies: lead

Related Publications (2)

• Berd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22.

  PMID: 14691123 BACKGROUND

• Berd D, Sato T, Cohn H, Maguire HC Jr, Mastrangelo MJ. Treatment of metastatic melanoma with autologous, hapten-modified melanoma vaccine: regression of pulmonary metastases. Int J Cancer. 2001 Nov;94(4):531-9. doi: 10.1002/ijc.1506.abs.

  PMID: 11745440 RESULT

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry E Schea

  AVAX Technologies

  STUDY DIRECTOR

Central Study Contacts

Henry E Schea

CONTACT

215 241-9760; henry@avax-tech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: July 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2021
• Last Updated: December 3, 2015

Record last verified: 2015-12