Is NCT01174121 recruiting in Bethesda, MD?

Yes, NCT01174121 is currently recruiting participants at its Bethesda, MD location. This metastatic colorectal cancer clinical trial is actively enrolling qualified participants.

How do I join the metastatic colorectal cancer clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Colorectal Cancer Clinical Trial in Bethesda, MD

About This Metastatic Colorectal Cancer Study in Bethesda

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.) Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.

Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.

Refractory to approved standard systemic therapy. Specifically:

Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.

Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.

Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.

Patients with 3 or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.

Age greater than or equal to 18 years and less than or equal to 72 years.

Clinical performance status of ECOG 0 or 1.

Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.

IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus. Serology

Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)

Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. Hematology

ANC \> 1000/mm\^3 without the support of filgrastim

WBC greater than or equal to 2500/mm\^3

Platelet count greater than or equal to 80,000/mm\^3

Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off. Chemistry

Serum ALT/AST less than or equal to 5.0 x ULN

Serum creatinine less than or equal to 1.5 x ULN

Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \< 3.0 mg/dL.

Patients must have completed any prior systemic therapy at the time of enrollment. Note: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.

Ability of subject to understand and the willingness to sign a written informed consent document.

Willing to sign a durable power of attorney.

Subjects must be co-enrolled on protocol 03-C-0277.

Exclusion Criteria

Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.

Concurrent systemic steroid therapy.

Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.

Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).

History of major organ autoimmune disease.

Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy.

Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)

History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.

History of coronary revascularization or ischemic symptoms.

For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.

Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.

For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.

Patients who are receiving any other investigational agents.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01174121) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Colorectal Cancer Treatment Options in Bethesda, MD

If you're searching for metastatic colorectal cancer treatment options in Bethesda, MD, this clinical trial (NCT01174121) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced metastatic colorectal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic colorectal cancer clinical trials near you to find additional studies recruiting in your area.

Metastatic Colorectal Cancer Clinical Trial in Bethesda, MD

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