Advertisement

Topics

Dinaciclib in Treating Patients With Stage III or Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

2014-07-23 21:11:32 | BioPortfolio

Summary

RATIONALE: Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with stage III or stage IV malignant melanoma that cannot be removed by surgery.

Description

OBJECTIVES:

Primary

- To determine the recommended phase II dose of dinaciclib administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I)

- To determine the 1-year overall survival of patients treated with dinaciclib at the dose and schedule derived in the phase I part of the study. (Phase II)

Secondary

- To characterize the safety profile and toxicities of dinaciclib.

- To determine the pharmacokinetics of dinaciclib.

- To determine the 6-month progression-free survival rate in patients treated with this drug. (Phase II)

- To determine the objective response rate in patients treated with this drug. (Phase II)

- To document cdk2, cdk2/1, and cdk9 inhibition in surrogate tissues and tumor.

- To correlate the degree of change of pharmacodynamic parameters in pre- and post-treatment samples with clinical outcome.

- To correlate the degree of change of parameters defining cdk2, cdk2/1, and cdk9 inhibition with pharmacokinetic parameters.

- To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition.

- To correlate pre-treatment cdk2 levels with clinical outcome.

- To correlate tumor p53 status with clinical outcome.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected periodically for pharmacokinetics and other correlative laboratory studies.

After completion of study treatment, patients are followed every 3 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

dinaciclib, laboratory biomarker analysis, pharmacological study

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:32-0400

Clinical Trials [3736 Associated Clinical Trials listed on BioPortfolio]

Dinaciclib in Treating Patients With Stage IV Melanoma

RATIONALE: Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well din...

Dinaciclib and Akt Inhibitor MK2206 in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery

This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by surgery. D...

Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients with melanoma receiving hydroxychloroquine may help doctors understand the effect of hydroxychl...

Veliparib and Dinaciclib With or Without Carboplatin in Treating Patients With Advanced Solid Tumors

This phase I trial studies the side effects and the best dose of veliparib and dinaciclib when given together with or without carboplatin in treating patients with solid tumors that have s...

Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma

RATIONALE: Dinaciclib may stop the growth of cancer cells by clocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving dinaciclib works...

PubMed Articles [36988 Associated PubMed Articles listed on BioPortfolio]

Efficacy of anti-PD-1 on skin carcinomas and melanoma metastases in an Xeroderma Pigmentosum patient.

Xeroderma pigmentosum is an orphan disease of poor prognosis. We report one case of parallel efficacy with anti-PD-1 antibody on both melanoma and skin carcinoma in a xeroderma pigmentosum patient. A ...

Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies.

Dinaciclib is a potent inhibitor of cell cycle and transcriptional cyclin-dependent kinases. This Phase 1 study evaluated the safety, tolerability and pharmacokinetics of various dosing schedules of d...

A cross-sectional study of the impact of educational information on topical photoprotection habits in medical students.

Skin cancer (melanoma and non-melanoma) is the most common cancer in humans, with melanoma being the most aggressive. Due to the fact that ultraviolet (UV) radiation exposure is the only adjustable ae...

Parkinson's Disease, Melanoma, and Keratinocyte Carcinoma: A Population-Based Study.

The association between Parkinson's disease (PD) and melanoma is well recognized, but its relationship with non-melanoma skin cancers has not been studied in depth.

MicroRNA‑675 inhibits cell proliferation and invasion in melanoma by directly targeting metadherin.

Melanoma is derived from melanocytes and accounts for ~80% of skin cancer-associated fatalities worldwide. The dysregulation of microRNAs (miRNAs/miRs) is involved in the development and progression o...

Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

More From BioPortfolio on "Dinaciclib in Treating Patients With Stage III or Stage IV Malignant Melanoma That Cannot Be Removed By Surgery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Skin cancers
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...


Searches Linking to this Trial