MDACC Study Summary 2004-0629 (Archived)

Study Summary
No. 2004-0629:.......Melanoma......Merrick I. Ross......Surgical Oncology

Study Summary Title



Study Summary Number:	2004-0629

Study Title:	A phase II study of matured dendritic cells pulsed ex vivo with 3 melanoma cell line lysates (IDD-3) in patients with in-transit or metastatic melanoma

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:	713-745-5252 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Visit 1 2 3 4 5 6 7 8 9 10 11 12-14 Study week* Baseline W0 W2 W4 W6 W8 W10 W12 W16 W22 W24 Wk 32, 40, 48

Treatment Agents:	IDD-3 Melacine Antigen Vaccine	Home Care:	NOT SPECIFIED OR GREATER THAN REGULAR VACCINATION FOR CANCER PATIENTS

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	NOT REQUIRED


Description/ Intervention:	The goal of this clinical research study is to find out if using modified (changed by adding extracts from melanoma tumor cell lines) dendritic cells (a type of white blood cells in your body) to make a vaccine (IDD-3) can help to strengthen your immune system against melanoma. The safety of using these modified cells will also be studied.

Study Objectives / Outcomes

PRIMARY
1. To assess the clinical activity (as measured by tumor control) following vaccine treatment in patients with in-transit or low volume metastatic melanoma

SECONDARY
1. To evaluate the immunologic activity of IDD-3 as measured by T Cell and antibody responses to lysate or to melanoma antigens or peptides.
2. To assess the safety of treatment as measured by the incidence and severity of adverse events, using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Study Status Information



Study Activation / Registration Date:	05/04/2005

IRB Review and Approval Date:	03/02/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	15-30 Depending on antitumor activity

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) Age >/= 18 years old

2) Patients with a histologically confirmed primary cutaneous melanoma or unknown primary melanoma with non-resected in-transit (Stage IIIc – N2c or N3), or distant skin, subcutaneous or lymph node (Stage IV - M1a), or pulmonary (Stage IV - M1b) metastases

3) Patients must have at least one measurable or evaluable lesion that can be followed throughout the study. Patients with lesions that are not measurable but which are still evaluable (e.g. small volume multiple cutaneous deposits) may be entered on study

4) Patients must have documented progressive disease (PD) before the initiation of treatment. PD is considered as at least 20% increase in size of at least one measurable/evaluable lesion or the appearance of one or more new lesions since or during last treatment (as applicable) and within 3 months prior to study entry

5) Life expectancy >/= 6 months

6) ECOG performance status 0-1

7) Adequate organ function as measured by: Serum creatinine </= 1.5 x upper limit of normal (ULN) Serum transaminases (SGOT & SGPT) </= 2.5 x upper limit of normal (ULN) WBC >/= 3.0 x 10(9)/L, platelets >/= 100 x10(9)/L, hemaglobin at least 10.0 g/dL (may be transfused)

8) Women of child bearing potential and fertile men are required to use effective contraception (negative bHCG for women of child-bearing age)

9) Written informed consent conforming to institutional guidelines

Exclusion Criteria:

1) Prior chemotherapy, radiation or biological therapy within 4 weeks (6 weeks for nitrosoureas) of study entry.

2) Prior vaccine therapy with one or more melanoma antigens or peptides

3) Positive serology (HIV 1 & 2, HTLV-I and II)

4) Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation

5) Contraindication to apheresis

6) Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

7) Active bacterial, viral or fungal infections within 72 hours of study entry

8) History of autoimmune disease or immunodeficiency syndrome, except vitiligo

9) Chronic systemic immunosuppressive treatment within 4 weeks prior to apheresis

10) Use of another investigational product within 4 weeks prior to study entry

11) Pregnant women or nursing women

12) Cerebral, bone or visceral (other than pulmonary) metastasis

13) Elevated LDH (< 1.5 x institutional upper limit of normal)

Links

Registration Number: NCT00107159
Study Information on Clinical Trials Registry (clinicaltrials.gov)