Gallium Ga 68-DOTA-5G and Lutetium Lu 177-DOTA-ABM-5G in Diagnosing and Treating Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Status: active

This phase I trial studies the effect of the theranostic pair, gallium Ga 68-DOTA-5G and lutetium Lu 177-DOTA-ABM-5G in diagnosing and treating patients with pancreatic cancer that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced, unresectable) or has spread to other places in the body (metastatic). These are radioactive molecules that can be used for either the detection of pancreatic cancer (when Gallium-68 is attached) or treatment of pancreatic cancer (when Lutetium-177 is attached). This pair of radiotracers is termed a “theranostic pair” because gallium Ga 68-DOTA-5G can be used for the diagnosis and determination of the extent of the cancer, while lutetium lu 177-DOTA-ABM-5G can be used for treatment by delivering targeted radioactivity. Gallium Ga 68-DOTA-5G and lutetium Lu 177-DOTA-ABM-5G may be an effective combination for diagnosing and treating patients with pancreatic cancer.

Inclusion Criteria

[68Ga]Ga DOTA-5G INCLUSION CRITERIA:
Ability to understand and willingness to sign a written informed consent document
Age 18 or more years
Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)
Participant must have documented tumor progression during or following at least one prior systemic regimen as established by diagnostic imaging
Eastern Cooperative Oncology Group performance status =< 2
Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA 5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to grade 1 or baseline
Absolute neutrophil count (ANC) >= 1000 cells/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin >= 8 g/dL
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase =< 5 times upper limit of normal (ULN)
Total bilirubin =< 2 times ULN
Creatinine =< 2 times ULN
Anticipated life expectancy >= 3 months
Able to remain motionless for up to 30-60 minutes per scan
[177Lu]Lu DOTA-ABM-5G INCLUSION CRITERIA:
Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax > 2-fold above normal lung or liver)

Exclusion Criteria

Participant on therapeutic warfarin anticoagulation
Participants with class 3 or 4 New York Heart Association (NYHA) congestive heart failure
Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
Pregnant or lactating women
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
Has an additional active malignancy requiring therapy within the past 2 years
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Psychiatric illness/social situations that would interfere with compliance with study requirements
Prior external beam radiation therapy to more than 25% of the bone marrow
Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs)
International normalized ratio (INR) > 2.0; partial thromboplastin time (PTT) > 15 seconds above UNL

PRIMARY OBJECTIVES:

I. To assess the ability of gallium Ga 68-DOTA-5G ([68Ga]Ga DOTA-5G) to detect lesions assessed by increased standard uptake value (maximum standard uptake value [SUVmax] > 2-fold above normal lung or liver) of [68Ga]Ga DOTA-5G in at least one lesion assessed by [68Ga]Ga DOTA-5G positron emission tomography/computed tomography (PET/CT).

II. To evaluate the safety and tolerability of [68Ga]Ga DOTA-5G and lutetium Lu 177-DOTA-ABM-5G ([177Lu]Lu DOTA-ABM-5G) assessed by the number of patients with treatment-related adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To determine the dose-limiting toxicities (DLT) of [177Lu]Lu DOTA-ABM-5G with activity levels starting from 25 mCi and increasing up to 200 mCi.

IV. To determine the maximum tolerated dose of [177Lu]Lu DOTA-ABM-5G to be used in a future phase II study.

EXPLORATORY OBJECTIVES:

I. To obtain from single photon emission computed tomography (SPECT/CT):

Ia. Area under curve (AUC) of [177Lu]Lu DOTA-ABM-5G in discernible thoracic and abdominal organs, target lesion, and blood.

Ib. Maximum uptake at the target lesion.

Ic. Maximum uptake in discernible organs.

Id. Organs receiving the highest absorbed dose assessed by equivalent dose to tissue (HT; sievert [Sv]).

Ie. Specific absorbed dose per organ (uGy/MBq).

If. Cumulative absorbed organ doses (Gy).

II. To evaluate the preliminary therapeutic efficacy of the maximum tolerated dose (MTD) of [177Lu]Lu DOTAABM-5G assessed by comparison with a post-treatment scan (either magnetic resonance imaging [MRI] or CT obtained during standard of care) using Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1) response in the expansion cohort.

IIa. Evaluate differences in RECIST response of different lesions, based on different [68Ga]Ga DOTA-5G uptake (standard uptake value [SUV]).

IIb. Evaluate differences in RECIST response of different lesions, based on different [177Lu]Lu DOTA-ABM-5G uptake (Gy).

IIc. Evaluate the change of alphavbeta6 levels (ng/mL) in blood pre and post [177Lu]Lu DOTA-ABM-5G treatment and determine correlation with the [177Lu]Lu DOTA-ABM-5G treatment response by RECIST criteria.

IId. Evaluate the predictive value of alphavbeta6 levels (ng/mL) in blood for the [177Lu]Lu DOTA-ABM-5G treatment response by RECIST criteria.

OUTLINE: This is a dose-escalation study of lutetium Lu 177-DOTA-ABM-5G.

Patients receive gallium Ga 68-DOTA-5G intravenously (IV) and then undergo PET/CT over 30 minutes. Patients with sufficient lesion uptake receive lutetium Lu 177-DOTA-ABM-5G IV within 1 month and undergo SPECT scans on days 1 and 7 and Ga 68-DOTA-5G PET/CT 30 days after treatment administration. Additionally, patients undergo blood sample collection on study.

After completion of study treatment, patients are followed up every 2 weeks for 90 days.

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Gallium Ga 68-DOTA-5G and Lutetium Lu 177-DOTA-ABM-5G in Diagnosing and Treating Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

United States

California

Sacramento

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Gallium Ga 68-DOTA-5G and Lutetium Lu 177-DOTA-ABM-5G in Diagnosing and Treating Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

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