The Clinical Grants and Contract Branch manages three Grant Programs - Clinical Oncology, Surgical Oncology and Cancer Nutrition. These Programs are composed of grants and cooperative agreements encompassing clinical agent development at the molecular, cellular and whole body levels as well as treatment regimen and methodology development. In addition, the AIDS Malignancy Program is administratively housed in CGCB. Information on that Program can be found at http://ctep.cancer.gov/resources/aidsmalignancy/. The CGCB also participates in the planning, implementation, and management of the clinical contracts program, the Clinical Trials Cooperative Groups, and other clinical consortia engaged in research to evaluate new agents and modalities for the treatment and management of cancer.
CGCB participates in extramural policy formulation, solicitation, budget development, and other associated activities. Staff develop and guide the processes and procedures for technical, administrative and fiscal management of CTEP'S extramural research and support contracts and coordinate the scientific review and award of the Program's contracts; helping to assure that the Program awards programmatically sound and technically appropriate contracts that conform to DCTD, NCI and NIH policies, and are consistent with sound scientific principles.
CGCB reviews existing and pending Clinical Oncology, Surgical Oncology, and
Cancer and Nutrition grants and cooperative agreements to ensure that a
proper scientific balance exists between funding mechanisms and identifies
areas of potential overlap between contracts, grants, and cooperative
agreements; identifies potential areas of scientific investigation and
develop plans to exploit the scientific potential of promising new agents,
modalities and treatment strategies; advises extramural investigators
on funding opportunities, mechanisms, and grant application process for
the Clinical Oncology, Surgical Oncology, and Cancer and Nutrition
Programs; and coordinates grantee interactions with other NCI
Branches/Programs for obtaining agents/resources to conduct funded
investigations.
Referral guidelines for the three Grant Programs are as follows:
Clinical Oncology: Clinical research studies designed to evaluate cancer
treatment. This category includes all Phase I, II, and III clinical trials
using drugs and biologic agents, Clinical trials in AIDS-related malignancies and gene therapy marking trials are also included. Preclinical studies that address specific issues related to the design of a clinical trial may be included in this category, but should not be the main objective of the grant application.
All clinical trials in which chemotherapeutic agents and/or biologic
agents are used as a major component of the treatment regimen. These studies
may employ:
- Chemotherapy alone or in combination with radiotherapy or surgery.
- Clinical studies (including Phase I and early Phase II trials) which contain the following:
- In vitro or in vivo tests done to predict the clinical response to cytotoxic and biologic therapies.
- Pharmacologic and immunologic monitoring of the agents (plasma and/or tissue).
- Modulation of drug toxicity and/or efficacy through chronotherapy.
- Use of agents to reverse resistance to or reduce toxicity from the cytotoxic therapy.
- Use of target specific delivery systems to enhance the selectivity and therapeutic effects of agents.
- Establishment of dose response relationship and efficacy.
- Studies conducted with the intent of selecting patients for therapy and predicting response to the specific therapies:
- Pharmacology of drug synergism and multi-agent therapy.
- Predictability, reversibility, and mechanisms of drug induced toxicity in vitro and/or in vivo test systems to access efficacy of therapy.
- Assessment of drug resistance in human tumors; reversal of clinical drug resistance.
- Assessment of prognostic factors (biological or molecular) that may predict response to specific treatment therapies.
- Clinical studies to reduce the toxicity of cytotoxic therapies by the use of agents such as:
- Colony stimulating factors.
- Radio/chemoprotective agents.
- Agents that bind free radicals.
- Clinical studies utilizing gene therapy and gene marking for tracking disease recurrence.
- All types of stem cell and bone marrow transplantation in cancer patients.
- Chemotherapy, immunotherapy, and stem cell and bone marrow transplantation for AIDS and HIV positive patients with cancer.
- Clinical studies using biological response modifiers or biological approaches to cancer treatment such as vaccines, immunotherapy, cellular therapy, antisense therapy, and liposomes.
- Clinical studies using agents directed at subcellular target sites including cell cycle targets, oncogenes, and suppressor genes.
- Clinical investigation, including experimental design, computer programming and biostatistics, and radiological histopathologic and immunologic support.
- Supportive care programs emphasizing preclinical and quality of life through supportive management of cancer patients undergoing antineoplastic treatment.
- Clinical trials using "unconventional therapies," including, but not limited to, behavioral and psychological approaches, dietary, herbal, pharmacologic and biologic treatments, and immuno-augmentative therapies (ref.: U.S. Congress, Office of Technology Assessment, Unconventional Cancer Treatments, OTA-H-405;; Washington, D.C.: U.S. Government Printing Office, September 1990).
Surgical Oncology:
- Intervention studies in which surgery is the dominant feature to prevent, diagnose, stage, or treat cancer; all surgical specialties, except neurosurgery and eyesurgery, are included.
- Special devices for dividing or destroying tissues, such as cryosurgery, laser surgery, or ultrasonic surgery; other studies in which surgery is the prominent feature in vascular access, dearterialization, hyperthermia, or infusion/perfusion with biological or chemotherapeutic agents.
- Development and improvement of instruments for detection or diagnosis of tumors where surgery/biopsies is the dominant feature in the process.
- Role of tumor suppressor genes on radiation induced apoptosis and cell cycle arrest of eukaryotic cells, particularly mammalian cells.
- Regulatory mechanisms controlling the expression of radiation induced apoptosis in mammalian cells. Molecular and cell biology underlying radiation carcinogenesis and teratogenesis in mammalian cells, transgenic and whole animal models:
- Role of ionizing radiation from both external sources and from internally deposited radionuclides as an initiator and promoter of cancer and/or developmental defects.
- Comparison of cellular, tissue and organ differences in susceptibility to radiation during development and in the mature animal.
- Molecular basis for differences in biological effectiveness between low and high LET radiation.
- Combined effects of radiation and other carcinogenic, mutagenic and teratogenic agents.
- Mechanism of action and effectiveness of radiation modifiers, including sensitizers and protectors.
- Identification and validation of biochemical and molecular markers for radiation exposure (e.g., mutation spectra, radiation induced damage repair proteins, radiation induced oncogenes, oncogene products, growth factors/receptors, cell surface proteins).
- Correlation of markers with radiation exposure as a function of dose, dose rate, and LET in both in vivo and in vitro biological systems.
- Determination of temporal and spatial relationships of marker expression with premalignant progression and frank malignancy in cells, tissues and organs.
- Mathematical modeling of epidemiological, animal, cellular, and molecular data to quantitate risks from low-level exposure to radiation.
Cancer and Nutrition:
- Nutritional assessment of the patient with diagnosed cancer.
- Methods - monitoring, assessing, and validating nutritional status and changes in these parameters.
- Definition of optimal nutritional status and requirements.
- Clinical relevance and comparison of nutritional parameters.
- Special assessment problems unique to cancer population.
- Body composition studies.
- Anthropometrics and other physical methods.
- Nutrient intake data pertaining to clinical trials involving cancer patients.
- Treatment effects on assessment parameter(s) or techniques.
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