Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Anti-Infective Agents

Hormones

Docetaxel

Isotretinoin

Interferons

Tretinoin

Interferon-alpha

Interferon-alfa-1b

Interferon alpha-2

Estramustine

Tubulin Modulators

Antimitotic Agents

Antiviral Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Hormonal

recombinant interferon alfa-2b

docetaxel

estramustine phosphate sodium

isotretinoin

polyacrylamide gel electrophoresis

protein expression analysis

immunohistochemistry staining method

Robert S. DiPaola, MD

RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

OBJECTIVES:

Primary

* Determine the response rate, in terms of change in measurable disease or prostate-specific antigen levels, in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin, recombinant interferon alfa-2b, docetaxel, and estramustine phosphate sodium.

Secondary

* Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients.

OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3, or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer

National Cancer Institute (NCI)

University of Medicine and Dentistry of New Jersey

Robert DiPaola, MD

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Rare Diseases

Congenital Abnormalities

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelomonocytic, Acute

Leukemia, Monocytic, Acute

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Monoblastic Leukemia

Acute Myelomonocytic Leukemia

Acute Erythroid Leukemia

Di Guglielmo's Syndrome

Acute Megakaryoblastic Leukemia

Acute Myeloblastic Leukemia With Maturation

Acute Myeloblastic Leukemia Without Maturation

western blotting

immunologic technique

laboratory biomarker analysis

Steven J. Collins, MD

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

OBJECTIVES:

* Determine whether calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) is associated with specific clinicopathological variables and outcomes in blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are analyzed by western blot using SDS-PAGE and immunoblotting using anti-calmodulin-dependent protein kinase II-γ (CaMKIIγ) and anti-phosphospecific (Thr286, 287) CaMKIIγ antibodies with signals detected via chemiluminescence. CaMKIIγ activation levels are linked to clinical variables within the SWOG database.

S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia

Determining the Clinicopathological Significance of CaMKIIgamma Activation in AML

SWOG Cancer Research Network

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.

polymerase chain reaction

DNA analysis

Michael Hogarty, MD

This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

OBJECTIVES:

I. Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group \[COG\] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases.

II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System \[INSS\] stage 1 and 2).

OUTLINE:

Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.

Study of DNA in Blood Samples From Patients With Neuroblastoma

Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma

Children's Oncology Group

Infections

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Papilloma

Virus Diseases

Oropharyngeal Cancer, Adult

gene expression analysis

mutation analysis

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

pharmacological study

Wendell G. Yarbrough, MD, FACS

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx.

OBJECTIVES:

* Analyze PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx.
* Determine proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells.
* Determine proliferation and survival after PI3K inhibition in short-term cultures of tumor tissue samples from patients with HPV(+) and HPV(-) primary SCC of the oropharynx.

OUTLINE: Previously collected tumor tissue samples are analyzed for HPV DNA by PCR amplification and direct sequencing of PCR products; expression of E6 protein and relative expression of PIK3CA by qRT-PCR; amplification of PIK3CA by Southern blotting; mutation of PIK3CA; expression of p110α, phospho-AKT, total AKT, and FOXO1 by polyacrylamide gel electrophoresis (PAGE) and immunoblotting; and the effect of PI3K inhibition on cell cycle and apoptosis by flow cytometry. Pharmacological studies are performed on oropharyngeal squamous cell carcinoma cell lines and short-term cultures and HPV E6 and E7 expressing cells using LY 294002 in vitro to analyze response to PI3K inhibition. Results of response to PI3K inhibition will be correlated with HPV status, PIK3CA expression, amplification, and mutation, and p110α expression.

PROJECTED ACCRUAL: A total of 20 HPV(+) and 20 HPV(-) tumor tissue specimens from patients will be accrued for this study.

DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx

Effect of PI3K Inhibition in HPV-Associated HNSCC

Vanderbilt University Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy	NCT00176527	Prostate Cancer	recombinant int... docetaxel estramustine ph... isotretinoin polyacrylamide ... protein express... immunohistochem...	18 Years -	Rutgers, The State University of New Jersey
S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia	NCT00899743	Leukemia	polyacrylamide ... western blottin... immunologic tec... laboratory biom...	56 Years -	SWOG Cancer Research Network
S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia	NCT00899743	Leukemia	polyacrylamide ... western blottin... immunologic tec... laboratory biom...	56 Years -	SWOG Cancer Research Network
Study of DNA in Blood Samples From Patients With Neuroblastoma	NCT00898391	Disseminated Ne... Localized Resec... Localized Unres... Recurrent Neuro... Regional Neurob... Stage 4S Neurob...	laboratory biom... polymerase chai... polyacrylamide ... DNA analysis	-	Children's Oncology Group
DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx	NCT00897988	Head and Neck C...	gene expression... mutation analys... polyacrylamide ... polymerase chai... protein express... reverse transcr... flow cytometry immunoenzyme te... immunologic tec... laboratory biom... pharmacological...	- 120 Years	Vanderbilt University Medical Center

Spots Global Cancer Trial Database for polyacrylamide gel electrophoresis