Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Colorectal Neoplasms

Melanoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

MelCancerVac

Anders Fischer, MD

Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer cells express some common antigens. Hence it is possible to use melanoma lysate to load the dendritic cells with tumor antigens similar to the antigens expressed by the patients' colorectal cancer cells.

The patient receives 10 vaccinations with 14 days between each. The parameters for effect are changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum concentration of carcinoembryonic antigen (CEA), performance status measured by the World Health Organization (WHO) criteria, and Quality of Life.

Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer

Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer

University Hospital, Gentofte, Copenhagen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Docetaxel

Antibodies

Antibodies, Monoclonal

Doxorubicin

Liposomal doxorubicin

Hormones

Immunoconjugates

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Immunologic Factors

SGN-15 (cBR96-doxorubicin immunoconjugate)

Taxotere (docetaxel)

Andrew Sandler, MD

SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.

The purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mAb) drug conjugate SGN-15 (cBR96 - Doxorubicin immunoconjugate), used in combination with the taxane agent, TAXOTERE (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (HRPC). This is a randomized, open label, phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC. Based on a previous phase I study of the SGN-15/TAXOTERE combination, the weekly dose of SGN-15 will be 200 mg/m2 and the weekly dose of TAXOTERE will be 35 mg/m2. The schedule of administration for both agents will be weekly, with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination. A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. The study will perform an interim analysis of the data after 80 patients have completed two courses. Patients should be treated for a minimum of 2 courses of therapy. Additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. Follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (QOL) assessment using a validated QOL instrument.

Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer

Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma

Seagen Inc.

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Natriuretic Agents

Vaccines

Ipilimumab

Mannitol

Monatide (IMS 3015)

Freund's Adjuvant

Adjuvants, Immunologic

Interleukin-12

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine

Jeffrey S. Weber, M.D., Ph.D.

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Novel Adjuvants for Peptide-Based Melanoma Vaccines

An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma

University of Southern California

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer	NCT00311272	Colorectal Neop...	MelCancerVac	25 Years - 75 Years	University Hospital, Gentofte, Copenhagen
Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer	NCT00031187	Prostatic Neopl...	SGN-15 (cBR96-d... Taxotere (docet...	18 Years -	Seagen Inc.
Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer	NCT00311272	Colorectal Neop...	MelCancerVac	25 Years - 75 Years	University Hospital, Gentofte, Copenhagen
Novel Adjuvants for Peptide-Based Melanoma Vaccines	NCT00028431	Melanoma	MDX-CTLA4 Antib...	18 Years -	University of Southern California
Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer	NCT00031187	Prostatic Neopl...	SGN-15 (cBR96-d... Taxotere (docet...	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for antigens, neoplasm