MDACC Study Summary 2005-0361 (Archived)

Study Summary
No. 2005-0361:.......Melanoma......Jeffrey E. Lee......Surgical Oncology

Study Summary Title



Study Summary Number:	2005-0361

Study Title:	M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma

Physician

New Patient Referral



Name:	Jeffrey E. Lee	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:	713-792-6940 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Once a month for 5 months and then once 3 months post surgery.

Treatment Agents:	BCG Cyclophosphamide Dinitrophenyl	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to find out if your white blood
cells are able to recognize the melanoma cells and attack them, after you have
been immunized with the melanoma cancer vaccine prepared from your own melanoma
cells; this is known as an "immunologic response." This immune system response
is the main objective of this research study. The safety of the vaccine will
also be studied.This study will not directly measure any beneficial effect of
the vaccine on any cancer in your body.

Study Objectives / Outcomes

Study Objectives

To study the toxicity, safety and DTH response of DNP-modified autologous melanoma tumor cell vaccine and the DTH response to unmodified melanoma tumor cells in patients with stage III or stage IV melanoma:
- To determine the tolerability and toxicity of M-Vax

- To determine whether M-Vax induces a DTH response to autologous, DNP-modified melanoma cells of similar magnitude to responses observed historically

- Determine whether M-Vax induces a DTH response to autologous unmodified melanoma cells

Study Endpoints

Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities for safety assessment.

Study Status Information



Study Activation / Registration Date:	08/30/2005

IRB Review and Approval Date:	07/20/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	80

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 resectable Stage III melanoma not candidates for standard high-dose interferon-alpha (Stage III adjuvant), or with Stage III in-transit disease not candidates for standard limb perfusion or alternative high-priority systemic therapy (Stage III in-transit disease), or with resectable Stage IV disease (Stage IV adjuvant), or with low-volume distant metastatic disease, including skin and subcutaneous metastases, distant nodal metastases, or lung metastases not candidates for alternative high-priority systemic therapy (low-volume Stage IV disease).

2) Surgery as standard therapy and for harvesting tumor mass yielding adequate cells for vaccine manufacture and DTH testing

3) Minimum of 3 maximum of 12 weeks since the surgery

4) Expected survival of at least 6 months

5) Karnofsky performance status greater than or equal to 80

6) Signed Informed Consent

Exclusion Criteria:

1) Alkaline phosphatase greater than 2.5 x ULN

2) Total bilirubin greater than 2.0 mg/dL

3) Creatinine greater than 2.0 mg/dL

4) Hemoglobin less than 10.0 g/dL

5) WBC less than 3,000 /mm(3)

6) Platelet count less than 100,000/mm(3)

7) Prior chemotherapy/radiotherapy within 4 weeks

8) Major field radiotherapy within 6 months prior to participation in the study

9) Prior immunotherapy (interferons, tumor necrosis factor, other cytokines [eg, interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study

10) Prior splenectomy

11) Concurrent use of systemic steroids (Note: Topical steroid therapies [applied to the skin] are not contraindicated for participation in the study, provided these are not applied to either arm. Inhaled aerosol steroids are not contraindicated for participation in the study)

12) Concurrent use of immunosuppressive drugs

13) Bilateral axillary node dissection with edema of both arms, precluding DTH testing

14) Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)

15) HIV 1/2 positive by ELISA, confirmed by Western blot

16) Hepatitis B surface antigen or hepatitis C antibody positive

17) Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostrate cancer

18) Autoimmune diseases that would interfere with an immunologic response (eg, systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis)

19) Concurrent medical condition that would preclude compliance or immunologic response to study treatment

20) Concurrent serious infection or other serious medical condition

21) Receipt of any investigational medication within 4 weeks prior to participation in the study

22) Pregnancy or lactation (serum Beta-human chronic gonadotropin [Beta-HCG] test must be negative in fertile women at screening visit)

23) Active tuberculosis or a past history of tuberculosis

24) Brain metastases

25) Liver metastases

26) Known gentamicin sensitivity

27) Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophycon (based upon availability)

28) Vaccine lot release failure

Links

Registration Number: NCT00257465
Study Information on Clinical Trials Registry (clinicaltrials.gov)