Genetically-informed Therapies for Patients With Metastatic Cancer

NCT02000739 | Withdrawn Phase 4 DMC

• 1 other identifier: D13214
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region. The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation. Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above. The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing. If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer. If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).

Conditions

Metastatic Cancer

Keywords

Breast cancer; melanoma; GI cancer; ovarian cancer; lung cancer; metastatic cancer; brain cancer; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression

  All patients considered for entry should be consented and have measurable disease as described in the Response Evaluation Criteria in Solid Tumors criteria. Within 4 weeks of cycle 1 day 1 the following are required: * CT Chest/abdomen/pelvis with contrast and bone scan or PET scan * Brain MRI or CT head with contrast- if indicated

  up to week 100

Study Arms (1)

Genetically Informed Therapy

OTHER

The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing. If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.

Genetic: Genetically Informed Therapy

Interventions

Genetically Informed Therapy GENETIC

If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.

Also known as: Patient Specific

Genetically Informed Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic cancer that has progressed by RECIST criteria on at least 1 prior therapy in the metastatic setting.
• Patients must have not received anti-cancer therapy (i.e., EGFR, BRAF, AR, ER or Her2 targeted agents , chemotherapy, radiation or surgery) within the last 4 weeks, and must have recovered to Grade 2 or better from all treatment-related adverse events.
• Karnofsky performance status ≥ 60%
• Women should not be lactating or pregnant. If of childbearing age, she must have a negative pregnancy test within two weeks of entry to the study and practice effective birth control during the study.
• Patient must be mentally competent and provide written informed consent for study participation.
• Tumor tissue must be obtained through a clinically indicated biopsy or surgical procedure, performed as standard-of-care for progression of disease.
• Patient must consent to the use of blood, plasma, and tumor tissues for research purposes. Only tumor genetic information will be used to recommend therapy in this study. Tumor, blood and/ or plasma may be retrospectively analyzed for research purposes.
• Patients must be willing to consent to paying for the supply of drug if necessary. Cost estimates will be provided at the time of consent. As per the current standard of care for prescription drugs, the treating oncologist and his/her staff will be responsible for making every effort to obtain reimbursement and/or find the lowest possible cost of drug to minimize out of pocket costs.

You may not qualify if:

• Concomitant second invasive malignancy within five years of enrollment except for non- melanoma skin cancer.
• In patients with a prior history of invasive malignancy, less than five years in complete remission.
• Evidence of significant comorbidities such as uncontrolled diabetes, hypertension or active infection that would preclude treatment on a proposed regimen.
• Prior treatment with proposed regimen.
• Clinically significant gastrointestinal abnormalities including but not limited to malabsorption syndrome, major resection of stomach or small bowel affecting absorption of oral drugs, active peptic ulcer disease, inflammatory bowel disease, history of small bowel obstruction abscess or fistula within 28 days prior to beginning study treatment.
• Presence of uncontrolled infection.
• Known lesion infiltrating major vessels, with risk of bleeding or perforation, as determined by radiographic review.
• Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
• Any ongoing toxicity from prior anti-cancer therapy that is Grade 3 or higher and /or progressing in severity.
• Untreated brain metastasis that have progressed within the 8-week period prior to enrollment.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms; Melanoma; Gastrointestinal Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Brain Neoplasms; Head and Neck Neoplasms

Interventions

Patient-Specific Modeling

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Models, Biological; Models, Theoretical; Investigative Techniques

Study Officials

• Mary D Chamberlin, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

US (1)