Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

leuprolide acetate

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses.

Study Design:

This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy.

A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months.

12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.

Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

GP-Pharm

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

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

Tremelimumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

pts treated at 10 mg/kg dose level on a monthly regimen

pts treated at 15 mg/kg dose level on a quarterly regimen

CP-675,206

The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma

CP-675,206 In Patients With Advanced Melanoma

Phase 1 Open Label, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Immune Function Effects, And Efficacy Of Multiple Doses Of CP-675,206 In Patients With Advanced Melanoma, And Phase 2, Open Label, Randomized Study To Evaluate the Efficacy, Safety, Tolerability And Pharmacokinetics Of 2 Regimens Of CP-675,206 In Patients With Advanced Melanoma.

AstraZeneca

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.

131I-TM601

Karen Fink, MD

Adam Mamelak, MD

Steven Rosenfeld, MD

Jan Drappatz, MD

Patrick Wen, MD

Jeffrey Olson, MD

Richard Wahl, MD

Heather Jacene, MD

Antonio Omuro, MD

Edward Pan, MD

Sean Grimm, MD

Jeffrey Raizer, MD

Nimish Mobile, MD

Marc Chamberlain, MD

Jay-Jiguang Zhu, MD

John Fiveash, MD

David Schiff, MD

Michael Edgeworth, MD

Mark Malkin, MD

Maciej Mrugala, MD

Steven Chmura, MD

Thomas Gribbin, MD

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.

This is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent malignant glioma.

The study will be conducted in two phases. Prior to initiating treatment as part of this study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During the first, Dose Escalation Phase of the study, eligible patients will be assigned in groups of 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase will be assigned to a dose determined by the experience in the first phase.

Patients in both study phases will have safety parameters evaluated continuously throughout the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days following the final study dose, and then at quarterly intervals scheduled at 3 month intervals following the first study dose, until disease progression.

A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma

TransMolecular

Susan Stewart, Vice President, Regulatory Affairs

Gliosarcoma

Anaplastic Astrocytoma

Oligoastrocytoma

Pharmaceutical Solutions

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

131-I-TM-601

131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.

This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.

The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.

High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.

Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.

131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer	NCT00128531	Prostate Cancer	leuprolide acet...	18 Years -	GP-Pharm
CP-675,206 In Patients With Advanced Melanoma	NCT00086489	Malignant Melan...	CP-675,206 CP-675,206	18 Years -	AstraZeneca
A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma	NCT00683761	Malignant Gliom... Glioblastoma Mu... GBM Astrocytoma Oligodendroglio...	131I-TM601	18 Years -	TransMolecular
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma	NCT00114309	Malignant Gliom... Glioblastoma Mu... GBM Anaplastic Astr... Oligo-Astrocyto... Gliosarcoma	131-I-TM-601 131I-TM601	18 Years -	TransMolecular
CP-675,206 In Patients With Advanced Melanoma	NCT00086489	Malignant Melan...	CP-675,206 CP-675,206	18 Years -	AstraZeneca

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