Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Mesothelioma

Mesothelioma, Malignant

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Vaccines

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

lung tumor associated antigen

DetoxPC

chemotherapy

cyclophosphamide

Timothy M. Anderson, MD

RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma.

OBJECTIVES: I. Define the immunological parameters of cytolytic T cell and T helper cell activity associated with skin testing and vaccination with autologous lung tumor associated antigen and detoxPC in patients with curatively resected stage I, II, or IIIA non-small cell lung cancer (NSCLC) or stage I or II mesothelioma. II. Evaluate any responses associated with an enhanced antitumor immune status in this patient population with this treatment regimen.

OUTLINE: Patients undergo delayed type hypersensitivity skin testing with autologous tumor associated antigen (TAA) and memory antigens (i.e., Monilia, PPD, and Trichophyton) intradermally at 1-4 weeks following surgical tumor resection. At week 4-9, patients receive low dose cyclophosphamide IV once. At 3 days following chemotherapy, patients receive autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks. At 2-3 weeks following vaccination, patients undergo repeat skin testing. At week 6-12, patients with a positive skin test undergo biopsy of the skin test/vaccination site followed by leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity. Patients with stable or regressive disease receive additional vaccination courses at week 20 and thereafter. Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.

Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma

An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen: Characterization of the Patients' Cytolytic and Helper T Cell Reactivity for Identification of the Specific Antigen(s): A Pilot Study

Roswell Park Cancer Institute

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Carcinoma

Carcinoma, Squamous Cell

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Recurrence

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Liver Neoplasms

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Carcinoma, Basal Cell

Papilloma

Nasopharyngeal Carcinoma

Thyroid Cancer, Papillary

Granuloma

Testicular Neoplasms

Thyroid Carcinoma, Anaplastic

Carcinoma, Adenoid Cystic

Carcinoid Tumor

Laryngeal Diseases

Esthesioneuroblastoma, Olfactory

Carcinoma, Medullary

Carcinoma, Verrucous

Adenocarcinoma, Follicular

Papilloma, Inverted

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Endometrial Neoplasms

Neoplasms, Germ Cell and Embryonal

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Liver Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pancreatic Cancer

Primary Liver Cancer

Small Cell Lung Cancer

Germ Cells Tumors

Papillary Thyroid Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Anaplastic Thyroid Cancer

Adenoid Cystic Carcinoma

Olfactory Neuroblastoma

Thyroid Cancer, Medullary

Testicular Germ Cell Tumor

Thyroid Cancer, Follicular

Mucoepidermoid Carcinoma

Metastatic Squamous Neck Cancer With Occult Primary

Midline Lethal Granuloma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Hematinics

Herbal and Botanical

Molgramostim

Sargramostim

Aldesleukin

Liver Extracts

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Cola

aldesleukin

ras peptide cancer vaccine

sargramostim

Barry L. Gause, MD

RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.

OBJECTIVES:

* Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients.
* Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation.
* Determine the type and characteristics of the cellular immune response generated.
* Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF.
* Correlate immune response with tumor response in patients treated with these regimens.

OUTLINE: Patients are assigned to one of three treatment groups.

* Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks.
* Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses.
* Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II.

In all groups, patients receive up to 15 vaccinations in the absence of disease progression.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.

Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors

Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma	NCT00003974	Lung Cancer Malignant Mesot...	lung tumor asso... DetoxPC chemotherapy cyclophosphamid...	20 Years - 70 Years	Roswell Park Cancer Institute
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors	NCT00019331	Colorectal Canc... Endometrial Can... Head and Neck C... Liver Cancer Lung Cancer Melanoma (Skin) Pancreatic Canc... Testicular Germ... Unspecified Adu...	aldesleukin ras peptide can... sargramostim DetoxPC	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for detoxpc

Every month we try and update this database with for detoxpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for detoxpc

Every month we try and update this database with for detoxpc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for detoxpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.