Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Rare Diseases

Uterine Cervical Neoplasms

Syndrome

Recurrence

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Pleural Effusion

Prostatic Neoplasms

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Stomach Neoplasms

Carcinoma, Renal Cell

Neoplasm Metastasis

Adenocarcinoma, Follicular

Lung Neoplasms

Pleural Effusion, Malignant

Urinary Bladder Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Liver Neoplasms

Breast Neoplasms, Male

Testicular Neoplasms

Thyroid Carcinoma, Anaplastic

Anus Neoplasms

Adrenocortical Carcinoma

Carcinoma, Adenoid Cystic

Carcinoid Tumor

Carcinoma, Medullary

Pericardial Effusion

Inflammatory Breast Neoplasms

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Glucagonoma

Zollinger-Ellison Syndrome

Somatostatinoma

Esophageal Cancer

Pancreatic Cancer

Papillary Thyroid Carcinoma

Bile Duct Cancer

Renal Cell Carcinoma

Thyroid Cancer, Follicular

Stomach Cancer

Vaginal Cancer

Primary Liver Cancer

Gallbladder Cancer

Breast Cancer, Male

Germ Cells Tumors

Anaplastic Thyroid Cancer

Anal Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Vulvar Cancer

Small Intestinal Adenocarcinoma

Adenoid Cystic Carcinoma

Thyroid Cancer, Medullary

Testicular Germ Cell Tumor

Inflammatory Breast Cancer

Small Intestine Cancer

Urethral Cancer

Parathyroid Carcinoma

Mucoepidermoid Carcinoma

WDHA Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Trastuzumab

Liver Extracts

Parathyroid Hormone

Tipifarnib

Pancreatic Polypeptide

Antineoplastic Agents, Immunological

Cola

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

trastuzumab

tipifarnib

Anthony W. Tolcher, MD

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.

II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.

III. Determine the antitumor activity of this treatment regimen in these patients.

IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study of R115777.

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

Patients are followed every 30 days until toxicity resolves.

Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer

National Cancer Institute (NCI)

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Necrosis

Melanoma

Sarcoma

Fibrosarcoma

Kidney Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Connective and Soft Tissue

Liver Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

colloidal gold-bound tumor necrosis factor

electron microscopy

pharmacological study

conventional surgery

Steven A. Rosenberg, MD, PhD

RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.

PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery for primary cancer or metastatic cancer .

OBJECTIVES:

Primary

* Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.

Secondary

* Determine, by histological examination of resected tumor tissue, the acute antitumor effects of this treatment in these patients.
* Determine the long-term toxicities of this treatment in these patients.
* Determine the response to this treatment in these patients.

OUTLINE: This is a cohort study. Patients are stratified according to disease type (colorectal cancer vs hepatocellular cancer vs pancreatic exocrine cancer vs pancreatic endocrine cancer vs breast cancer vs melanoma vs primary adrenal tumors vs renal cell carcinoma).

Patients receive colloidal gold-bound tumor necrosis factor IV over 15-30 seconds 12-78 hours prior to surgery. Patients then undergo standard-care surgery.

Tumor and normal tissues are removed during surgery for analysis of antitumor effects and tissue distribution of colloidal gold-bound tumor necrosis factor by electron microscopy.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.

Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer

An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection

National Institutes of Health Clinical Center (CC)

Anti-Inflammatory Agents

Vasoconstrictor Agents

Respiratory System Agents

Anti-Infective Agents

Dermatologic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Racepinephrine

Epinephryl borate

Suramin

Hydrocortisone-17-butyrate

Anthelmintics

Antiparasitic Agents

Antiprotozoal Agents

suramin

therapeutic hydrocortisone

Louis E. Schroder, MD

RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing.

PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.

OBJECTIVES: I. Assess the response of patients with adrenocortical carcinoma treated with suramin. II. Evaluate the qualitative and quantitative toxic effects of this therapy.

OUTLINE: Patients are described according to stage, performance status, prior radiotherapy, prior surgery, and prior mitotane therapy. Patients receive suramin IV for 5 days in the first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks. Hydrocortisone is taken PO twice daily. Following a 12 week rest, patients receive a second course; those with stable or responding disease continue treatment for a maximum of four courses.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued at a rate of 6-7 per year.

S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

SWOG Cancer Research Network

Reproductive Control Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Gossypol acetic acid

Gossypol

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Contraceptive Agents

Contraceptive Agents, Male

Contraceptive Agents, Female

Spermatocidal Agents

Retinol

Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Participants take 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

R-(-)-gossypol acetic acid

Michael Menefee

This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVE:

I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid.

SECONDARY OBJECTIVES::

I. To evaluate the safety of this drug in these patients. II. To determine the progression-free and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery

A Phase II Study of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients With Advanced Adrenocortical Carcinoma (ACC)

In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.

Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.

The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer	NCT00436410	Adrenocortical ... Breast Cancer Colorectal Canc... Gastrointestina... Kidney Cancer Liver Cancer Melanoma (Skin) Ovarian Cancer Pancreatic Canc... Sarcoma	colloidal gold-... electron micros... pharmacological... conventional su...	18 Years -	National Institutes of Health Clinical Center (CC)
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery	NCT00002921	Adrenocortical ...	suramin therapeutic hyd...	18 Years -	SWOG Cancer Research Network
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery	NCT00848016	Recurrent Adren... Stage III Adren... Stage IV Adreno...	R-(-)-gossypol ...	18 Years -	National Cancer Institute (NCI)
IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery	NCT00778817	Recurrent Adren... Stage III Adren... Stage IV Adreno...	IMC-A12 mitotane	18 Years -	National Cancer Institute (NCI)
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery	NCT00848016	Recurrent Adren... Stage III Adren... Stage IV Adreno...	R-(-)-gossypol ...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iii adrenocortical carcinoma