Solid Tumors/Lymphomas

May 09, 2017

Sponsor: National Cancer Institute (NCI)

Number: EAY131

This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications/enlarging, or translocations/rearrangements) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Who’s eligible:

• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration. Patients that are pregnant or breast feeding are excluded. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 24 consecutive months
    (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study. Should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately.
• Patients must have histologically (tissue microscopically examined) documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
  • Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls). Patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met;
    OR
  • Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• Patients must have measurable disease.
• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.