MDACC Study Summary 2003-0720

Study Summary
No. 2003-0720:.......Melanoma......Merrick I. Ross......Surgical Oncology

Study Summary Title



Study Summary Number:	2003-0720

Study Title:	EVALUATION OF LOCAL GM-CSF-IN-ADJUVANT AND THE NUMBER OF VACCINE SITES ON IMMUNIZATION WITH MULTIPLE SYNTHETIC MELANOMA PEPTIDES

Physician

New Patient Referral



Name:	Merrick I. Ross	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7217 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Evaluations will be performed on days 1, 8, 15, 22, 29, 36, 43, 50, weeks 12, 26, 39, 52, and at 13 and month 24.

Treatment Agents:	GM-CSF Peptide Vaccine	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:

Study Objectives / Outcomes

To estimate: (1) whether GM-CSF administered locally changes the immunogenicity of vaccination with multiple synthetic melanoma peptides in an emulsion with incomplete Freund's adjuvant, (2) whether vaccination at two extremity sites induces different immunogenicity than vaccination at a single site. Secondary goals are to obtain preliminary data on (3) whether booster vaccination every three months maintains immune responses to a peptide vaccine, and (4) whether cellular immune responses to a 12-peptide vaccine correlate with clinical outcome.

Study Status Information



Study Activation / Registration Date:	05/03/2004

IRB Review and Approval Date:	02/18/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	124

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with stage IIB, IIC, III or IV melanoma that have no evidence of disease (NED) after surgical resection (may have had cutaneous or mucosal primary melanoma, or unknown primary melanoma). Staging must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on the revised AJCC staging system (90). Mucosal melanomas will be based on the following system modified from the cutaneous melanoma staging system: clinically localized primary melanomas > 4 mm in thickness = stage IIB, lymph node metastases = stage III, distant metastases = stage IV

2) Patients will be required to have radiological studies to rule out clinically evident disease. Required studies include chest x-ray or chest CT scan, abdominal and pelvic CT scan, and head CT scan or MRI. Total body PET scan may replace scans of the chest, abdomen, and pelvis.

3) Patients who have had brain metastases will be eligible if all of the following are true: The total number of brain metastases ever is less than or equal to 3. The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry. There has been no evident growth of any brain metastasis since treatment. No brain metastasis is greater than 2 cm in diameter at the time of protocol entry.

4) Surgical resections or gamma-knife must have been completed less than or equal to 6 months prior to study entry.

5) The IFN education packet must be completed satisfactorily for those who are eligible for, but refuse, IFN. This packet is available from the Human Immune Therapy Center, University of Virginia.

6) All patients must have ECOG performance status of 0 or 1. Ability and willingness to give informed consent.

7) Laboratory parameters as follows: HLA-A1, -A2 or -A3 (+), ANC > 1000/mm3, and Platelets > 100,000/microliter and Hgb > 9 g/dL, Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN, Renal: Creatinine up to 1.5 x ULN, Serology (within 6 months of study entry), HIV negative, Hepatitis C negative, and LDH up to 1.5 x ULN.

8) Age 12 years or older at the time of study entry.

9) Patients must have at least two intact (undissected) axillary and/or inguinal lymph node basins.

Exclusion Criteria:

1) Patients with ocular melanoma.

2) Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 4 weeks. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.

3) Patients with known or suspected allergies to any component of the vaccine.

4) Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded: Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents). Allergy desensitization injections. Corticosteroids, administered parenterally or orally. Inhaled steroids (e.g.: Advair) are not permitted. Topical corticosteroids are acceptable. Any growth factors. Interleukin-2 or other interleukins.

5) Patients may not have been vaccinated previously with any of the synthetic peptides that are included in this protocol.

6) Patients who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination.

7) Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to randomization. Males and females must agree, in the consent from, to use effective birth control methods during the course of vaccination. Women must also not be breastfeeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.

8) Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.

9) Patients who have systemic autoimmune disease with visceral involvement. Patients must not have active autoimmune disorders requiring cytotoxic or immunosuppressive therapy. The following will not be exclusionary: The present of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms, clinical evidence of vitiligo, other forms of depigmenting illness, or mild arthritis requiring NSAID medications.

10) Patients who have another cancer diagnosis, except that the following diagnoses will be allowed: squamous cell cancer of the skin without known metastasis, basal cell cancer of the skin without known metastasis, carcinoma in situ of the breast (DCIS or LCIS), carcinoma in situ of the cervix, any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years.

11) Patients with known addiction to alcohol or drugs who is actively taking those agents, or patients with recent (within 1 year) or ongoing illicit IV drug use.

12) Body weight less than 110 pounds (without clothes) at study entry, due to the amount and frequency with which blood will be drawn.

13) Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.

Links

Registration Number: NCT00089193
Study Information on Clinical Trials Registry (clinicaltrials.gov)